Identity
- Trade Name
- Alliant Biotech FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Device Name
- Unicompartmental Tibial Poly Size 2 16mm FDA UDI
- Model / Reference
- Size 2x16 FDA UDI
- Description
- Unicompartmental Tibial Poly Size 2 16mm FDA UDI
Identifiers
- Catalog Number
- WZ-1-1028 FDA UDI
- Primary DI / UDI-DI
- G611WZ110280 FDA UDI
- 510(k) Number
- K012800 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Unicondylar knee 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Unicondylar knee insert
Alliant Biotech by Medisurge — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee insert.
- Vivacit-E® — Zimmer, Inc. · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- MOTO Partial Knee System - Medial — Medacta International · Class II
- GENESIS — Smith & Nephew, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- GMK Uni — Medacta International · Class II
- SIGMA — DEPUY (IRELAND) · Class II
- GENESIS — Smith & Nephew, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medisurge
Sources (1)
- FDA UDI 66c7a2f6-7ed3-4511-85f8-8ae63a596a29 36 fields · synced Jun 8, 2026