Identity
- Trade Name
- Virage® OCT FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- Open-Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm) FDA UDI
- Model / Reference
- 300P0010 FDA UDI
- Description
- Open-Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm) FDA UDI
Identifiers
- Catalog Number
- 300P0010 FDA UDI
- Primary DI / UDI-DI
- 03662663079846 FDA UDI
- 510(k) Number
- K250332 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system connector
Virage® OCT by Highridge Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K250332 also covers:
- Virage OCT Spinal Fixation System — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
- Virage® OCT — Highridge Medical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Highridge Medical, LLC
Sources (1)
- FDA UDI cdbda39c-39be-44ce-960b-0c0e4bc744fa 36 fields · synced May 30, 2026