Identity
- Trade Name
- VBR FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- ostapek cage FDA UDI
- Model / Reference
- 29.084 FDA UDI
- Description
- ostapek cage FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640173161752 FDA UDI
- 510(k) Number
- K072326 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Vbr by coLigne AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K072326 also covers:
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
- coLigne AG
Sources (1)
- FDA UDI b79cce90-9ac7-4f5e-b615-81bc72a29563 36 fields · synced Jun 1, 2026