Identity
- Trade Name
- Uni Tibial Insert FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Uni Tibial Insert 5x14 FDA UDI
- Model / Reference
- 5x14 FDA UDI
- Description
- Uni Tibial Insert 5x14 FDA UDI
Identifiers
- Catalog Number
- WZ-1-1039 FDA UDI
- Primary DI / UDI-DI
- B046WZ110390 FDA UDI
- 510(k) Number
- K012800 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tibial insert
Uni Tibial Insert by Signal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K012800 also covers:
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
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
- Signal Medical Corp.
Sources (1)
- FDA UDI 48c797cd-68d3-4c05-8816-6c6b0e597afd 36 fields · synced Jun 1, 2026