Pure Global

​Globus Medical CALIBER Spacers - HSA Registration DE0501451

Access comprehensive regulatory information for ​Globus Medical CALIBER Spacers in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501451 and owned by Globus Medical Inc.. The device was registered on March 29, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0501451
​Globus Medical CALIBER Spacers
HSA Registration Number: DE0501451
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

​CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or more levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0501451
Registration Date
March 29, 2018
Change Notification Approval Date
March 05, 2025
Retention Due Date
March 28, 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)
CALIBERL Spacer 18 x 40mm, 8-11mm, Trailing Taper CALIBERL Spacer 18 x 45mm, 8-11mm, Trailing Taper CALIBERL Spacer 18 x 50mm, 8-11mm, Trailing Taper CALIBERL Spacer 18 x 55mm, 8-11mm, Trailing Taper CALIBERL Spacer 18 x 60mm, 8-11mm, Trailing Taper CALIBERL Spacer 18 x 40mm, 8-11mm, Leading Taper CALIBERL Spacer 18 x 45mm, 8-11mm, LeadingTaper CALIBERL Spacer 18 x 50mm, 8-11mm, Leading Taper CALIBERL Spacer 18 x 55mm, 8-11mm, Leading Taper CALIBERL Spacer 18 x 60mm, 8-11mm, Leading Taper CALIBERL Spacer 18 x 40mm, 9-12mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 45mm, 9-12mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 50mm, 9-12mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 55mm, 9-12mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 60mm, 9-12mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 40mm, 9-12mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 45mm, 9-12mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 50mm, 9-12mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 55mm, 9-12mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 60mm, 9-12mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 40mm, 10-14mm, Trailing Taper CALIBERL Spacer 18 x 45mm, 10-14mm, Trailing Taper CALIBERL Spacer 18 x 50mm, 10-14mm, Trailing Taper CALIBERL Spacer 18 x 55mm, 10-14mm, Trailing Taper CALIBERL Spacer 18 x 60mm, 10-14mm, Trailing Taper CALIBERL Spacer 18 x 40mm, 10-14mm, Leading Taper CALIBERL Spacer 18 x 45mm, 10-14mm, Leading Taper CALIBERL Spacer 18 x 50mm, 10-14mm, Leading Taper CALIBERL Spacer 18 x 55mm, 10-14mm, Leading Taper CALIBERL Spacer 18 x 60mm, 10-14mm, Leading Taper CALIBERL Spacer 18 x 40mm, 11-15mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 45mm, 11-15mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 50mm, 11-15mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 55mm, 11-15mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 60mm, 11-15mm, Trailing Taper, Lordotic CALIBERL Spacer 18 x 40mm, 11-15mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 45mm, 11-15mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 50mm, 11-15mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 55mm, 11-15mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 60mm, 11-15mm, Leading Taper, Lordotic CALIBERL Spacer 18 x 40mm, 12-16mm, Trailing Taper CALIBERL Spacer 18 x 45mm, 12-16mm, Trailing Taper CALIBERL Spacer 18 x 50mm, 12-16mm, Trailing Taper CALIBERL Spacer 18 x 55mm, 12-16mm, Trailing Taper CALIBERL Spacer 18 x 60mm, 12-16mm, Trailing Taper CALIBER Spacer 10 x 22mm, 8-12mm CALIBER Spacer 10 x 26mm, 8-12mm CALIBER Spacer 10 x 30mm, 8-12mm CALIBERL Spacer 18 x 40mm, 12-16mm, Leading Taper CALIBERL Spacer 18 x 45mm, 12-16mm, Leading Taper CALIBERL Spacer 18 x 50mm, 12-16mm, Leading Taper CALIBERL Spacer 18 x 55mm, 12-16mm, Leading Taper CALIBERL Spacer 18 x 60mm, 12-16mm, Leading Taper CALIBER Spacer 10 x 22mm, 10-15mm CALIBER Spacer 10 x 26mm, 10-15mm CALIBER Spacer 10 x 30mm, 10-15mm CALIBER Spacer 10 x 22mm, 7mm, 0°-10° CALIBER Spacer 10 x 26mm, 7mm, 0°-10° CALIBER Spacer 10 x 30mm, 7mm, 0°-10° CALIBER Spacer 10 x 22mm, 8mm, 0°-12° CALIBER Spacer 10 x 26mm, 8mm, 0°-12° CALIBER Spacer 10 x 30mm, 8mm, 0°-12° CALIBER Spacer 10 x 22mm, 12-17mm CALIBER Spacer 10 x 26mm, 12-17mm CALIBER Spacer 10 x 30mm, 12-17mm CALIBER Spacer 10 x 22mm, 9-13mm CALIBER Spacer 10 x 26mm, 9-13mm CALIBER Spacer 10 x 30mm, 9-13mm CALIBER Spacer 10 x 22mm, 7-10mm CALIBER Spacer 10 x 26mm, 7-10mm CALIBER Spacer 10 x 30mm, 7-10mm CALIBER Spacer 10 x 22mm, 9-13mm, 12° Lordotic CALIBER Spacer 10 x 26mm, 9-13mm, 12° Lordotic CALIBER Spacer 10 x 30mm, 9-13mm, 12° Lordotic CALIBER Spacer 10 x 22mm, 11 -15mm, 15° CALIBER Spacer 10 x 26mm, 11-15mm, 15° CALIBER Spacer 10 x 30mm, 11-15mm, 15° CALIBER Spacer 10 x 22mm, 12-17mm, 15° CALIBER Spacer 10 x 26mm, 12-17mm, 15° CALIBER Spacer 10 x 30mm, 12-17mm, 15° CALIBER Spacer 10 x 22mm, 7mm CALIBER Spacer 10 x 26mm, 7mm CALIBER Spacer 10 x 30mm, 7mm CALIBER Spacer 12 x 26mm, 7mm CALIBER Spacer 12 x 30mm, 7mm CALIBER Spacer 12 x 26mm, 8-12mm CALIBER Spacer 12 x 30mm, 8-12mm CALIBER Spacer 12 x 26mm, 10-15mm CALIBER Spacer 12 x 30mm, 10-15mm CALIBER Spacer 12 x 26mm, 7mm, 0°-10° CALIBER Spacer 12 x 30mm, 7mm, 0°-10° CALIBER Spacer 12 x 26mm, 8mm, 0°-12° CALIBER Spacer 12 x 30mm, 8mm, 0°-12° CALIBER Spacer 12 x 26mm, 12-17mm CALIBER Spacer 12 x 30mm, 12-17mm CALIBER Spacer 12 x 26mm, 9-13mm CALIBER Spacer 12 x 30mm, 9-13mm CALIBER Spacer 12 x 26mm, 7-10mm CALIBER Spacer 12 x 30mm, 7-10mm CALIBER Spacer 12 x 26mm, 9-13mm, 12° Lordotic CALIBER Spacer 12 x 30mm, 9-13mm, 12° Lordotic CALIBER Spacer 12 x 26mm, 11-15mm, 15° CALIBER Spacer 12 x 30mm, 11-15mm, 15° CALIBER Spacer 12 x 26mm, 12-17mm, 15° CALIBER Spacer 12 x 30mm, 12-17mm, 15°
Model Identifier(s)
194.001 194.002 194.003 194.004 194.005 194.011 194.012 194.013 194.014 194.015 194.021 194.022 194.023 194.024 194.025 194.031 194.032 194.033 194.034 194.035 194.041 194.042 194.043 194.044 194.045 194.051 194.052 194.053 194.054 194.055 194.061 194.062 194.063 194.064 194.065 194.071 194.072 194.073 194.074 194.075 194.101 194.102 194.103 194.104 194.105 194.122 194.126 194.130 194.201 194.202 194.203 194.204 194.205 194.222 194.226 194.230 194.272 194.273 194.274 194.282 194.283 194.284 194.322 194.326 194.330 194.422 194.426 194.430 194.510 194.511 194.512 194.610 194.611 194.612 194.822 194.826 194.830 194.922 194.926 194.930 394.022 394.026 394.030 394.126 394.130 594.126 594.130 594.226 594.230 594.273 594.274 594.283 594.284 594.326 594.330 594.426 594.430 594.511 594.512 594.611 594.612 594.826 594.830 594.926 594.930