Identity
- Trade Name
- PHYSICA FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- Tibial Plate #5 FDA UDI
- Model / Reference
- Fixed Tibial Plate FDA UDI
- Description
- Tibial Plate #5 FDA UDI
Identifiers
- Catalog Number
- 6522.15.050 FDA UDI
- Primary DI / UDI-DI
- 08033390089920 FDA UDI
- 510(k) Number
- K141934 FDA UDI
- FDA Product Code
- JWH FDA UDIHRY FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3530 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uncoated knee tibia prosthesis, metallic
Physica by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, metallic.
- Natural-Knee® — Zimmer, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K141934 also covers:
- MULTIGEN PLUS Knee — Limacorporate
- PHYSICA — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
- PHYSICA Instrument Set — Limacorporate
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
- Limacorporate
Sources (1)
- FDA UDI a5f254b8-a1b6-4566-9b23-5e0ceb7c401a 36 fields · synced Jun 1, 2026