Globus Medical ELLIPSE® Occipito-Cervico-Thoracic Spinal System - HSA Registration DE0501901
Access comprehensive regulatory information for Globus Medical ELLIPSE® Occipito-Cervico-Thoracic Spinal System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501901 and owned by Globus Medical Inc.. The device was registered on July 17, 2018.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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HSA Official Data
CLASS C
DE0501901
Globus Medical ELLIPSE® Occipito-Cervico-Thoracic Spinal System
HSA Registration Number: DE0501901
Product Description
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito- cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions or placement in the cervical spine (C2-C7) in treating cervical conditions. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0501901
Registration Date
July 17, 2018
Change Notification Approval Date
March 05, 2025
Retention Due Date
July 16, 2025
Product Owner
Short Name
Globus Medical Inc.
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, Pennsylvania, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
30 KALLANG PLACE, #06-06, SINGAPORE 339159
Model Information
Model Name(s)
4.0mm Standard Screw, Self-Tapping, 6mm
4.0mm Standard Screw, Self-Tapping, 8mm
4.0mm Standard Screw, Self-Tapping, 10mm
4.0mm Standard Screw, Self-Tapping, 12mm
4.0mm Standard Screw, Self-Tapping, 14mm
4.0mm Standard Screw, Self-Tapping, 16mm
4.5mm Standard Screw, Self-Tapping, 6mm
4.5mm Standard Screw, Self-Tapping, 8mm
4.5mm Standard Screw, Self-Tapping, 10mm
4.5mm Standard Screw, Self-Tapping, 12mm
4.5mm Standard Screw, Self-Tapping, 14mm
4.5mm Standard Screw, Self-Tapping, 16mm
3.5mm CAPITOL Curved Rod, 40mm
3.5mm CAPITOL Curved Rod, 50mm
3.5mm CAPITOL Curved Rod, 60mm
3.5mm CAPITOL Curved Rod, 70mm
3.5mm CAPITOL Curved Rod, 80mm
3.5mm CAPITOL Curved Rod, 90mm
3.5mm CAPITOL Curved Rod, 110mm
3.5mm CAPITOL Curved Rod, 120mm
3.5mm ELLIPSE Polyaxial Screw, 10mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 12mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 14mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 16mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 18mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 20mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 22mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 24mm Tapered Tip
3.5mm ELLIPSE Polyaxial Screw, 26mm Tapered Tip
3.5mm ELLIPSE Polyaxial Shoulder Screw, 22mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 24mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 26mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 28mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 30mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 32mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 34mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 36mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 38mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 40mm
3.5mm ELLIPSE Polyaxial Shoulder Screw, 42mm
3.5mm ELLIPSE Polyaxial Screw, 8mm
3.5mm ELLIPSE Polyaxial Screw, 10mm
3.5mm ELLIPSE Polyaxial Screw, 12mm
3.5mm ELLIPSE Polyaxial Screw, 14mm
3.5mm ELLIPSE Polyaxial Screw, 16mm
3.5mm ELLIPSE Polyaxial Screw, 18mm
3.5mm ELLIPSE Polyaxial Screw, 20mm
3.5mm ELLIPSE Polyaxial Screw, 22mm
3.5mm ELLIPSE Polyaxial Screw, 24mm
3.5mm ELLIPSE Polyaxial Screw, 26mm
3.5mm ELLIPSE Polyaxial Screw, 28mm
3.5mm ELLIPSE Polyaxial Screw, 30mm
3.5mm ELLIPSE Polyaxial Screw, 32mm
3.5mm ELLIPSE Polyaxial Screw, 34mm
3.5mm ELLIPSE Polyaxial Screw, 36mm
3.5mm ELLIPSE Polyaxial Screw, 38mm
3.5mm ELLIPSE Polyaxial Screw, 40mm
3.5mm ELLIPSE Polyaxial Screw, 42mm
3.5mm ELLIPSE Polyaxial Screw, 44mm
3.5mm ELLIPSE Polyaxial Screw, 46mm
3.5mm ELLIPSE Polyaxial Screw, 48mm
3.5mm ELLIPSE Polyaxial Screw, 50mm
4.0mm ELLIPSE Polyaxial Screw, 10mm
4.0mm ELLIPSE Polyaxial Screw, 12mm
4.0mm ELLIPSE Polyaxial Screw, 14mm
4.0mm ELLIPSE Polyaxial Screw, 16mm
4.0mm ELLIPSE Polyaxial Screw, 18mm
4.0mm ELLIPSE Polyaxial Screw, 20mm
4.0mm ELLIPSE Polyaxial Screw, 22mm
4.0mm ELLIPSE Polyaxial Screw, 24mm
4.0mm ELLIPSE Polyaxial Screw, 26mm
4.0mm ELLIPSE Polyaxial Screw, 28mm
4.0mm ELLIPSE Polyaxial Screw, 30mm
4.0mm ELLIPSE Polyaxial Screw, 32mm
4.0mm ELLIPSE Polyaxial Screw, 34mm
4.0mm ELLIPSE Polyaxial Screw, 36mm
4.0mm ELLIPSE Polyaxial Screw, 38mm
4.0mm ELLIPSE Polyaxial Screw, 40mm
4.0mm ELLIPSE Polyaxial Screw, 42mm
4.0mm ELLIPSE Polyaxial Screw, 44mm
4.0mm ELLIPSE Polyaxial Screw, 46mm
4.0mm ELLIPSE Polyaxial Screw, 48mm
4.0mm ELLIPSE Polyaxial Screw, 50mm
Hook Left, 3mm
Hook Left, 5mm
Hook Left, 7mm
Hook Left, 9mm
Hook Right, 3mm
Hook Right, 5mm
Hook Right, 7mm
Hook Right, 9mm
ELLIPSE Inline Hook, 3mm
ELLIPSE Inline Hook, 5mm
ELLIPSE Inline Hook, 7mm
ELLIPSE Inline Hook, 9mm
ELLIPSE Locking Cap
ELLIPSE Inline Hook
ELLIPSE Inline Hook, Right
ELLIPSE Inline Hook, Left
ELLIPSE Offset Hook, Left, 7mm
ELLIPSE Offset Hook, Left, 5mm
ELLIPSE Offset Hook, Right, 7mm
ELLIPSE Offset Hook, Right, 5mm
4.5mm ELLIPSE Polyaxial Screw, 10mm
4.5mm ELLIPSE Polyaxial Screw, 12mm
4.5mm ELLIPSE Polyaxial Screw, 14mm
4.5mm ELLIPSE Polyaxial Screw, 16mm
4.5mm ELLIPSE Polyaxial Screw, 18mm
4.5mm ELLIPSE Polyaxial Screw, 20mm
4.5mm ELLIPSE Polyaxial Screw, 22mm
4.5mm ELLIPSE Polyaxial Screw, 24mm
4.5mm ELLIPSE Polyaxial Screw, 26mm
4.5mm ELLIPSE Polyaxial Screw, 28mm
4.5mm ELLIPSE Polyaxial Screw, 30mm
4.5mm ELLIPSE Polyaxial Screw, 32mm
4.5mm ELLIPSE Polyaxial Screw, 34mm
4.5mm ELLIPSE Polyaxial Screw, 36mm
4.5mm ELLIPSE Polyaxial Screw, 38mm
4.5mm ELLIPSE Polyaxial Screw, 40mm
4.5mm ELLIPSE Polyaxial Screw, 42mm
4.5mm ELLIPSE Polyaxial Screw, 44mm
4.5mm ELLIPSE Polyaxial Screw, 46mm
4.5mm ELLIPSE Polyaxial Screw, 48mm
4.5mm ELLIPSE Polyaxial Screw, 50mm
In-Line Connector, CT to CT
In-Line Connector, CT to TL
Rod-to-Rod Clamp, CT to CT, 7mm
Rod-to-Rod Clamp, Double, CT to CT, 7mm
Rod-to-Rod Clamp, CT to TL, 8mm
Rod-to-Rod Clamp, Double, CT to TL, 8mm
Parallel Connector Clamp, CT to CT, 7mm
Parallel Connector Clamp, CT to TL , 8mm
Parallel Connector Clamp, Double, CT to CT, 7mm
Parallel Connector Clamp, Double, CT to TL, 8mm
Parallel Connector, 3.5mm Rod to 3.5mm Rod, 9mm
Parallel Connector, 3.5mm Rod to 4.0mm Rod, 9mm
Parallel Connector, 3.5mm Rod to 4.5mm Rod, 10mm
Parallel Connector, 3.5mm Rod to 5.0mm Rod, 10mm
Parallel Connector, 3.5mm Rod to 5.5mm Rod, 10mm
Parallel Connector, 3.5mm Rod to 6.0mm Rod, 10mm
Parallel Connector, 3.5mm Rod to 6.35mm Rod, 10mm
Parallel Connector, 3.5mm Rod to 6.5mm Rod, 10mm
Rod-to-Rod Clamp, CT to CT, 9mm
Rod-to-Rod Clamp, Double, CT to CT, 9mm
Rod-to-Rod Clamp, CT to TL, 10mm
Rod-to-Rod Clamp, Double, CT to TL, 10mm
Parallel Connector Clamp, CT to CT, 9mm
Parallel Connector Clamp, CT to TL , 10mm
Parallel Connector Clamp, Double, CT to CT, 9mm
Parallel Connector Clamp, Double, CT to TL, 10mm
3.5mm ELLIPSE Rod, 80mm
3.5mm ELLIPSE Rod, 120mm
3.5mm ELLIPSE Rod, 240mm
3.5mm ELLIPSE Rod, 40mm
In-Line Extension CT Clamp, 3.5mm Rod, Left
In-Line Extension CT Clamp, 3.5mm Rod, Right
Offset Extension CT Clamp, 5.5mm Rod, Left
Offset Extension CT Clamp, 5.5mm Rod, Right
Offset Extension CT Clamp, 6.35mm Rod, Left
Offset Extension CT Clamp, 6.35mm Rod, Right
Offset Extension TL Clamp, 3.5mm Rod, Left
Offset Extension TL Clamp, 3.5mm Rod, Right
CT U-Clamp, 5.5mm Rod, Left
CT U-Clamp, 5.5mm Rod, Right
CT U-Clamp, 6.35mm Rod, Left
CT U-Clamp, 6.35mm Rod, Right
TL U-Clamp, 3.5mm Rod, Left
TL U-Clamp, 3.5mm Rod, Right
ELLIPSE Locking Cap for Head-to-Head T-Connector
ELLIPSE Locking Nut for Head-to-Head T-Connector
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 21-27mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 27-33mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 33-39mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 39-45mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 45-51mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 51-57mm
ELLIPSE Head to Head T-Connector for 3.5mm Rod, 57-63mm
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 21-33, Straight
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 26-46, Curved
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 26-46, straight
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 36-56, Curved
ELLIPSE Top-Loading T-Connector for 3.5mm Rod, 36-56, Straight
ELLIPSE Occipital Plate, Small
ELLIPSE Occipital Plate, Large
3.5mm ELLIPSE Occipital Rod, 240mm, 100deg
3.5mm ELLIPSE Occipital Rod, 240mm, 115deg
3.5mm ELLIPSE Occipital Rod, 240mm, 130deg
Occipital Jointed Rod, Right
Occipital Jointed Rod, Left
ELLIPSE Parallel Connector 3.5mm Rod to 3.5mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 4.0mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 4.5mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 5.0mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 5.5mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 6.0mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 6.35mm Rod
ELLIPSE Parallel Connector 3.5mm Rod to 6.5mm Rod
ELLIPSE Lateral Connector
ELLIPSE Tapered Rod, 3.5mm to 5.5mm, 700mm
ELLIPSE Tapered Rod, 3.5mm to 3.7mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 4.0mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 4.5mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 5.0mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 5.5mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 6.0mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 6.35mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 6.5mm, 350mm
ELLIPSE Tapered Rod, 3.5mm to 5.5mm, 550mm
ELLIPSE Tapered Rod, 3.5mm to 5.5mm, 500mm
ELLIPSE Lateral Connector, Long
ELLIPSE Lateral Connector, Short
ELLIPSE Lateral Connector, Angled
ELLIPSE Head Lateral Connector, 15mm
ELLIPSE Head Lateral Connector, 20mm
Lateral Connector, Closed, 15mm
Lateral Connector, Closed, 20mm
3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 8mm
3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
4.0mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
4.0mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
4.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
4.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
3.5mm CoCr Rod, 80mm
3.5mm CoCr Rod, 120mm
3.5mm CoCr Rod, 240mm
3.5mm CoCr Rod, 40mm
3.5mm CoCr Occipital Rod 240mm, 100°
3.5mm CoCr Occipital Rod 240mm, 114°
3.5mm CoCr Occipital Rod 240mm, 130°
CoCr Tapered Rod, 3.5mm to 5.5mm, 700mm
CoCr Tapered Rod, 3.5mm to 3.7mm, 350mm
CoCr Tapered Rod, 3.5mm to 4.0mm, 350mm
CoCr Tapered Rod, 3.5mm to 4.5mm, 350mm
CoCr Tapered Rod, 3.5mm to 5.0mm, 350mm
CoCr Tapered Rod, 3.5mm to 5.5mm, 350mm
CoCr Tapered Rod, 3.5mm to 6.0mm, 350mm
CoCr Tapered Rod, 3.5mm to 6.35mm, 350mm
CoCr Tapered Rod, 3.5mm to 6.5mm, 350mm
CoCr Tapered Rod, 3.5mm to 5.5mm, 500mm
Model Identifier(s)
110.806
110.808
110.810
110.812
110.814
110.816
110.906
110.908
110.910
110.912
110.914
110.916
111.840
111.850
111.860
111.870
111.880
111.890
111.910
111.920
182.010
182.012
182.014
182.016
182.018
182.020
182.022
182.024
182.026
182.222
182.224
182.226
182.228
182.230
182.232
182.234
182.236
182.238
182.240
182.242
182.308
182.310
182.312
182.314
182.316
182.318
182.320
182.322
182.324
182.326
182.328
182.330
182.332
182.334
182.336
182.338
182.340
182.342
182.344
182.346
182.348
182.350
182.410
182.412
182.414
182.416
182.418
182.420
182.422
182.424
182.426
182.428
182.430
182.432
182.434
182.436
182.438
182.440
182.442
182.444
182.446
182.448
182.450
182.488
182.489
182.490
182.491
182.492
182.493
182.494
182.495
182.496
182.497
182.498
182.499
182.500
182.501
182.503
182.504
182.506
182.507
182.508
182.509
182.510
182.512
182.514
182.516
182.518
182.520
182.522
182.524
182.526
182.528
182.530
182.532
182.534
182.536
182.538
182.540
182.542
182.544
182.546
182.548
182.550
182.724
182.725
182.741
182.743
182.745
182.747
182.749
182.751
182.753
182.755
182.760
182.761
182.762
182.763
182.764
182.765
182.766
182.767
182.770
182.771
182.772
182.773
182.774
182.775
182.776
182.777
182.801
182.802
182.803
182.804
182.820
182.821
182.822
182.823
182.824
182.825
182.826
182.827
182.828
182.829
182.830
182.831
182.832
182.833
182.900
182.901
182.911
182.912
182.913
182.914
182.915
182.916
182.917
182.923
182.924
182.925
182.926
182.927
182.950
182.952
182.953
182.954
182.955
182.956
182.957
182.960
182.961
182.962
182.963
182.964
182.965
182.966
182.967
182.975
182.977
182.979
182.980
182.981
182.982
182.983
182.984
182.985
182.986
182.988
182.989
182.990
182.991
182.992
182.993
182.994
182.995
182.996
582.308
582.310
582.312
582.410
582.412
582.510
582.512
782.801
782.802
782.803
782.804
782.953
782.954
782.955
782.977
782.979
782.980
782.981
782.982
782.983
782.984
782.985
782.986
782.989