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Globus Medical REVOLVEยฎ Stabilization System - HSA Registration DE0501604

Access comprehensive regulatory information for Globus Medical REVOLVEยฎ 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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CLASS C
DE0501604
Globus Medical REVOLVEยฎ Stabilization System
HSA Registration Number: DE0501604
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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)
185.000 185.081 185.082 185.083 185.084 185.085 185.240 185.245 185.250 185.255 185.260 185.265 185.270 185.275 185.280 185.290 185.300 185.310 185.320 185.330 185.340 185.350 185.360 185.370 185.380 185.390 185.400 185.410 185.420 185.430 185.440 185.441 185.442 185.443 185.444 185.445 185.446 185.447 185.452 185.453 185.454 185.455 185.456 185.457 185.462 185.463 185.464 185.465 185.466 185.467 185.468 185.469 185.472 185.473 185.474 185.475 185.476 185.477 185.478 185.479 185.482 185.483 185.484 185.485 185.486 185.487 185.488 185.489 185.500 185.840 185.845 185.850 185.855 185.860 185.865 185.870 185.875 185.880 185.890 185.900 185.910 185.920 185.930 185.940 185.950 585.141 585.142 585.143 585.144 585.145 585.146 585.147 585.151 585.152 585.153 585.154 585.155 585.156 585.157 585.161 585.162 585.163 585.164 585.165 585.166 585.167 585.241 585.242 585.243 585.244 585.245 585.246 585.247 585.251 585.252 585.253 585.254 585.255 585.256 585.257 585.261 585.262 585.263 585.264 585.265 585.266 585.267 585.341 585.342 585.343 585.344 585.345 585.346 585.347 585.351 585.352 585.353 585.354 585.355 585.356 585.357 585.361 585.362 585.363 585.364 585.365 585.366 585.367 585.368 585.369 585.371 585.372 585.373 585.374 585.375 585.376 585.377 585.378 585.379 585.381 585.382 585.383 585.384 585.385 585.386 585.387 585.388 585.389 585.390 585.391 585.392 585.393 585.394 785.240 785.245 785.250 785.255 785.260 785.265 785.270 785.275 785.280 785.290 785.300 785.310 785.320 785.330 785.340 785.360 785.370 785.380 785.390 785.400 785.410 785.420 785.430 785.440 785.500 785.550 785.600 785.650 785.700 785.840 785.845 785.850 785.855 785.860 785.865 785.870 785.875 785.880 785.890 785.900 785.910 785.920 785.930 785.940 785.950