Identity
- Trade Name
- primaLOK SP FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- Auxiliary Instrument Case FDA UDI
- Model / Reference
- 800-0501 FDA UDI
- Description
- Auxiliary Instrument Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813210021365 FDA UDI
- 510(k) Number
- K100354 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
primaLOK SP by Wenzel Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100354 also covers:
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzel Spine
Sources (1)
- FDA UDI 00b6e3e9-08bd-4ab4-96bf-55e37199bb31 35 fields · synced May 31, 2026