Identity
- Trade Name
- Alliant Biotech FDA UDI
- Generic Name
- Coated unicondylar knee femur prosthesis FDA UDI
- Device Name
- Unicompartmental Femoral Knee Size 3 FDA UDI
- Model / Reference
- Size 3 FDA UDI
- Description
- Unicompartmental Femoral Knee Size 3 FDA UDI
Identifiers
- Catalog Number
- WZ-1-1003 FDA UDI
- Primary DI / UDI-DI
- G611WZ110030 FDA UDI
- 510(k) Number
- K012800 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Coated unicondylar knee femur prosthesis 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: Coated unicondylar knee femur prosthesis
Alliant Biotech by Medisurge — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated unicondylar knee femur prosthesis.
- MOTO Partial Knee System — Medacta International · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- UNI LM/RL XLG — BIOPRO, INC. · Class II
- UNI LM/RL LG — BIOPRO, INC. · Class II
- UNI LL/RM LG — BIOPRO, INC. · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- MOTO Partial Knee System — Medacta International · Class II
- MOTO Partial Knee System — Medacta International · 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 25662966-62ed-4c4c-a065-e8b028103f7b 36 fields · synced Jun 1, 2026