Globus Medical REVOLVE® Stabilization System - HSA Registration DE0501604
Access comprehensive regulatory information for Globus Medical REVOLVE® Stabilization 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 DE0501604 and owned by Globus Medical Inc.. The device was registered on May 03, 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
DE0501604
Globus Medical REVOLVE® Stabilization System
HSA Registration Number: DE0501604
Product Description
When used as a posterior pedicle screw system, it is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. System is also intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0501604
Registration Date
May 03, 2018
Change Notification Approval Date
March 05, 2025
Retention Due Date
May 02, 2026
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)
REVOLVE Locking Cap
8.5mm REVOLVE Polyaxial Pedicle Screw, 70mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 75mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 80mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 85mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 90mm
5.5mm REVOLVE Rod, 40mm
5.5mm REVOLVE Rod, 45mm
5.5mm REVOLVE Rod, 50mm
5.5mm REVOLVE Rod, 55mm
5.5mm REVOLVE Rod, 60mm
5.5mm REVOLVE Rod, 65mm
5.5mm REVOLVE Rod, 70mm
5.5mm REVOLVE Rod, 75mm
5.5mm REVOLVE Rod, 80mm
5.5mm REVOLVE Rod, 90mm
5.5mm REVOLVE Rod, 100mm
5.5mm REVOLVE Rod, 110mm
5.5mm REVOLVE Rod, 120mm
5.5mm REVOLVE Rod, 130mm
5.5mm REVOLVE Rod, 140mm
5.5mm REVOLVE Rod, 150mm
5.5mm REVOLVE Rod, 160mm
5.5mm REVOLVE Rod, 170mm
5.5mm REVOLVE Rod, 180mm
5.5mm REVOLVE Rod, 190mm
5.5mm REVOLVE Rod, 200mm
5.5mm REVOLVE Rod, 210mm
5.5mm REVOLVE Rod, 220mm
5.5mm REVOLVE Rod, 230mm
5.5mm REVOLVE Rod, 240mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 25mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 30mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 35mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 40mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 45mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 50mm
5.0mm REVOLVE Polyaxial Pedicle Screw, 55mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 30mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 35mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 40mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 45mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 50mm
5.5mm REVOLVE Polyaxial Pedicle Screw, 55mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 30mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 35mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 40mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 45mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 50mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 55mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 60mm
6.5mm REVOLVE Polyaxial Pedicle Screw, 65mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 30mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 35mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 40mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 45mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 50mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 55mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 60mm
7.5mm REVOLVE Polyaxial Pedicle Screw, 65mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 30mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 35mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 40mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 45mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 50mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 55mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 60mm
8.5mm REVOLVE Polyaxial Pedicle Screw, 65mm
5.5mm REVOLVE Rod, 300mm
5.5mm REVOLVE Rod, Extra Lordotic, 40mm
5.5mm REVOLVE Rod, Extra Lordotic, 45mm
5.5mm REVOLVE Rod, Extra Lordotic, 50mm
5.5mm REVOLVE Rod, Extra Lordotic, 55mm
5.5mm REVOLVE Rod, Extra Lordotic, 60mm
5.5mm REVOLVE Rod, Extra Lordotic, 65mm
5.5mm REVOLVE Rod, Extra Lordotic, 70mm
5.5mm REVOLVE Rod, Extra Lordotic, 75mm
5.5mm REVOLVE Rod, Extra Lordotic, 80mm
5.5mm REVOLVE Rod, Extra Lordotic, 90mm
5.5mm REVOLVE Rod, Extra Lordotic, 100mm
5.5mm REVOLVE Rod, Extra Lordotic, 110mm
5.5mm REVOLVE Rod, Extra Lordotic, 120mm
5.5mm REVOLVE Rod, Extra Lordotic, 130mm
5.5mm REVOLVE Rod, Extra Lordotic, 140mm
5.5mm REVOLVE Rod, Extra Lordotic, 150mm
5.0mm REVOLVE Uniplanar Screw, 25mm
5.0mm REVOLVE Uniplanar Screw, 30mm
5.0mm REVOLVE Uniplanar Screw, 35mm
5.0mm REVOLVE Uniplanar Screw, 40mm
5.0mm REVOLVE Uniplanar Screw, 45mm
5.0mm REVOLVE Uniplanar Screw, 50mm
5.0mm REVOLVE Uniplanar Screw, 55mm
5.5mm REVOLVE Uniplanar Screw, 25mm
5.5mm REVOLVE Uniplanar Screw, 3 mm
5.5mm REVOLVE Uniplanar Screw, 35mm
5.5mm REVOLVE Uniplanar Screw, 40mm
5.5mm REVOLVE Uniplanar Screw, 45mm
5.5mm REVOLVE Uniplanar Screw, 50mm
5.5mm REVOLVE Uniplanar Screw, 55mm
6.5mm REVOLVE Uniplanar Screw, 25mm
6.5mm REVOLVE Uniplanar Screw, 30mm
6.5mm REVOLVE Uniplanar Screw, 35mm
6.5mm REVOLVE Uniplanar Screw, 40mm
6.5mm REVOLVE Uniplanar Screw, 45mm
6.5mm REVOLVE Uniplanar Screw, 50mm
6.5mm REVOLVE Uniplanar Screw, 55mm
5.0mm REVOLVE Uniplanar Fracture Screw, 25mm
5.0mm REVOLVE Uniplanar Fracture Screw, 30mm
5.0mm REVOLVE Uniplanar Fracture Screw, 35mm
5.0mm REVOLVE Uniplanar Fracture Screw, 40mm
5.0mm REVOLVE Uniplanar Fracture Screw, 45mm
5.0mm REVOLVE Uniplanar Fracture Screw, 50mm
5.0mm REVOLVE Uniplanar Fracture Screw, 55mm
5.5mm REVOLVE Uniplanar Fracture Screw, 25mm
5.5mm REVOLVE Uniplanar Fracture Screw, 30mm
5.5mm REVOLVE Uniplanar Fracture Screw, 35mm
5.5mm REVOLVE Uniplanar Fracture Screw, 40mm
5.5mm REVOLVE Uniplanar Fracture Screw, 45mm
5.5mm REVOLVE Uniplanar Fracture Screw, 50mm
5.5mm REVOLVE Uniplanar Fracture Screw, 55mm
6.5mm REVOLVE Uniplanar Fracture Screw, 25mm
6.5mm REVOLVE Uniplanar Fracture Screw, 30mm
6.5mm REVOLVE Uniplanar Fracture Screw, 35mm
6.5mm REVOLVE Uniplanar Fracture Screw, 40mm
6.5mm REVOLVE Uniplanar Fracture Screw, 45mm
6.5mm REVOLVE Uniplanar Fracture Screw, 50mm
6.5mm REVOLVE Uniplanar Fracture Screw, 55mm
5.0mm REVOLVE Monoaxial Screw, 25mm
5.0mm REVOLVE Monoaxial Screw, 30mm
5.0mm REVOLVE Monoaxial Screw, 35mm
5.0mm REVOLVE Monoaxial Screw, 40mm
5.0mm REVOLVE Monoaxial Screw, 45mm
5.0mm REVOLVE Monoaxial Screw, 50mm
5.0mm REVOLVE Monoaxial Screw, 55mm
5.5mm REVOLVE Monoaxial Screw, 25mm
5.5mm REVOLVE Monoaxial Screw, 30mm
5.5mm REVOLVE Monoaxial Screw, 35mm
5.5mm REVOLVE Monoaxial Screw, 40mm
5.5mm REVOLVE Monoaxial Screw, 45mm
5.5mm REVOLVE Monoaxial Screw, 50mm
5.5mm REVOLVE Monoaxial Screw, 55mm
6.5mm REVOLVE Monoaxial Screw, 25mm
6.5mm REVOLVE Monoaxial Screw, 30mm
6.5mm REVOLVE Monoaxial Screw, 35mm
6.5mm REVOLVE Monoaxial Screw, 40mm
6.5mm REVOLVE Monoaxial Screw, 45mm
6.5mm REVOLVE Monoaxial Screw, 50mm
6.5mm REVOLVE Monoaxial Screw, 55mm
6.5mm REVOLVE Monoaxial Screw, 60mm
6.5mm REVOLVE Monoaxial Screw, 65mm
7.5mm REVOLVE Monoaxial Screw, 25mm
7.5mm REVOLVE Monoaxial Screw, 30mm
7.5mm REVOLVE Monoaxial Screw, 35mm
7.5mm REVOLVE Monoaxial Screw, 40mm
7.5mm REVOLVE Monoaxial Screw, 45mm
7.5mm REVOLVE Monoaxial Screw, 50mm
7.5mm REVOLVE Monoaxial Screw, 55mm
7.5mm REVOLVE Monoaxial Screw, 60mm
7.5mm REVOLVE Monoaxial Screw, 65mm
8.5mm REVOLVE Monoaxial Screw, 25mm
8.5mm REVOLVE Monoaxial Screw, 30mm
8.5mm REVOLVE Monoaxial Screw, 35mm
8.5mm REVOLVE Monoaxial Screw, 40mm
8.5mm REVOLVE Monoaxial Screw, 45mm
8.5mm REVOLVE Monoaxial Screw, 50mm
8.5mm REVOLVE Monoaxial Screw, 55mm
8.5mm REVOLVE Monoaxial Screw, 60mm
8.5mm REVOLVE Monoaxial Screw, 65mm
8.5mm REVOLVE Monoaxial Screw, 70mm
8.5mm REVOLVE Monoaxial Screw, 75mm
8.5mm REVOLVE Monoaxial Screw, 80mm
8.5mm REVOLVE Monoaxial Screw, 85mm
8.5mm REVOLVE Monoaxial Screw, 90mm
5.5mm REVOLVE Rod, CoCr, 40mm
5.5mm REVOLVE Rod, CoCr, 45mm
5.5mm REVOLVE Rod, CoCr, 50mm
5.5mm REVOLVE Rod, CoCr, 55mm
5.5mm REVOLVE Rod, CoCr, 60mm
5.5mm REVOLVE Rod, CoCr, 65mm
5.5mm REVOLVE Rod, CoCr, 70mm
5.5mm REVOLVE Rod, CoCr, 75mm
5.5mm REVOLVE Rod, CoCr, 80mm
5.5mm REVOLVE Rod, CoCr, 90mm
5.5mm REVOLVE Rod, CoCr, 100mm
5.5mm REVOLVE Rod, CoCr, 110mm
5.5mm REVOLVE Rod, CoCr, 120mm
5.5mm REVOLVE Rod, CoCr, 130mm
5.5mm REVOLVE Rod, CoCr, 140mm
5.5mm REVOLVE Rod, CoCr, 160mm
5.5mm REVOLVE Rod, CoCr, 170mm
5.5mm REVOLVE Rod, CoCr, 180mm
5.5mm REVOLVE Rod, CoCr, 190mm
5.5mm REVOLVE Rod, CoCr, 200mm
5.5mm REVOLVE Rod, CoCr, 210mm
5.5mm REVOLVE Ro , CoCr, 220mm
5.5mm REVOLVE Rod, CoCr, 230mm
5.5mm REVOLVE Rod, CoCr, 240mm
5.5mm REVOLVE Rod, CoCr, 300mm
5.5mm REVOLVE Rod, CoCr, 350mm
5.5mm REVOLVE Rod, CoCr, 400mm
5.5mm REVOLVE Rod, CoCr, 450mm
5.5mm REVOLVE Rod, CoCr, 500mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 40mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 45mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 50mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 55mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 60mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 65mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 70mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 75mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 80mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 90mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 100mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 110mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 120mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 130mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 140mm
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 150mm
Model Identifier(s)
185.000
185.081
185.082
185.083
185.084
185.085
185.240
185.245
185.250
185.255
185.260
185.265
185.270
185.275
185.280
185.290
185.300
185.310
185.320
185.330
185.340
185.350
185.360
185.370
185.380
185.390
185.400
185.410
185.420
185.430
185.440
185.441
185.442
185.443
185.444
185.445
185.446
185.447
185.452
185.453
185.454
185.455
185.456
185.457
185.462
185.463
185.464
185.465
185.466
185.467
185.468
185.469
185.472
185.473
185.474
185.475
185.476
185.477
185.478
185.479
185.482
185.483
185.484
185.485
185.486
185.487
185.488
185.489
185.500
185.840
185.845
185.850
185.855
185.860
185.865
185.870
185.875
185.880
185.890
185.900
185.910
185.920
185.930
185.940
185.950
585.141
585.142
585.143
585.144
585.145
585.146
585.147
585.151
585.152
585.153
585.154
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585.156
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585.341
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585.372
585.373
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585.375
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585.377
585.378
585.379
585.381
585.382
585.383
585.384
585.385
585.386
585.387
585.388
585.389
585.390
585.391
585.392
585.393
585.394
785.240
785.245
785.250
785.255
785.260
785.265
785.270
785.275
785.280
785.290
785.300
785.310
785.320
785.330
785.340
785.360
785.370
785.380
785.390
785.400
785.410
785.420
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785.440
785.500
785.550
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785.650
785.700
785.840
785.845
785.850
785.855
785.860
785.865
785.870
785.875
785.880
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785.900
785.910
785.920
785.930
785.940
785.950