Virage® OCT
- Primary DI
- 03662663079822
- Brand
- Virage® OCT
- Company
- Highridge Medical, LLC
- Model
- 300P0006
- Catalog number
- 300P0006
- Device description
- Axial 2 Screw Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
- Published
- 2025-04-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| NKB | Thoracolumbosacral pedicle screw system |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K250332 | 000 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | 2025-04-04 | NKG |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03662663079822 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system connector | An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(800)447-3625 | usbrocustomerservice@highridgemedical.com |
Regulatory Flags
- DUNS number
- 119260394
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|
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| 03662663130936 | Zyston Interbody Spacer System | 136M3307 | 136M3307 | 2026-03-17 |
| 03662663131117 | Zyston Interbody Spacer System | 139M2606 | 139M2606 | 2026-03-17 |
| 03662663136693 | Polaris 5.5 Spinal Fixation System | 14-501810 | 14-501810 | 2026-03-17 |
| 03662663136709 | Polaris 5.5 Spinal Fixation System | 14-501811 | 14-501811 | 2026-03-17 |
| 03662663136723 | Polaris 5.5 Spinal Fixation System | 14-501813 | 14-501813 | 2026-03-17 |
| 03662663143462 | MaxAn Anterior Cervical Plate System | 14-522038 | 14-522038 | 2026-03-17 |
| 03662663143479 | MaxAn Anterior Cervical Plate System | 14-522039 | 14-522039 | 2026-03-17 |
| 03662663143486 | MaxAn Anterior Cervical Plate System | 14-522040 | 14-522040 | 2026-03-17 |
| 03662663143493 | MaxAn Anterior Cervical Plate System | 14-522041 | 14-522041 | 2026-03-17 |
| 03662663143509 | MaxAn Anterior Cervical Plate System | 14-522042 | 14-522042 | 2026-03-17 |
| 03662663143516 | MaxAn Anterior Cervical Plate System | 14-522043 | 14-522043 | 2026-03-17 |
| 03662663143523 | MaxAn Anterior Cervical Plate System | 14-522044 | 14-522044 | 2026-03-17 |
| 03662663143530 | MaxAn Anterior Cervical Plate System | 14-522045 | 14-522045 | 2026-03-17 |
| 03662663085458 | FlareHawk | ASY-00003 | ASY-00003 | 2025-10-03 |
| 03662663085502 | FlareHawk | ASY-00018 | ASY-00018 | 2025-10-03 |
| 03662663085533 | FlareHawk | ASY-00040 | ASY-00040 | 2025-10-03 |
| 03662663085540 | FlareHawk | ASY-00041 | ASY-00041 | 2025-10-03 |
| 03662663085632 | FlareHawk | ASY-00064 | ASY-00064 | 2025-10-03 |
| 03662663085663 | FlareHawk | ASY-00067 | ASY-00067 | 2025-10-03 |
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