Identity
- Trade Name
- Plasma Coated NTK System FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Device Name
- NTK STEM FEMUR FDA UDI
- Model / Reference
- 117.031P FDA UDI
- Description
- NTK STEM FEMUR FDA UDI
Identifiers
- Catalog Number
- 117.031P FDA UDI
- Primary DI / UDI-DI
- 05055343893708 FDA UDI
- 510(k) Number
- K980545 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Coated knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Radiation Sterilization FDA UDI
Category: Coated knee femur prosthesis
Plasma Coated NTK System by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee femur prosthesis.
- PHYSICA POROUS PS — Limacorporate · Class II
- GMK Primary Total Knee System — Medacta International · Class II
- PHYSICA POROUS KR — Limacorporate · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- Persona® PPS® — Zimmer, Inc. · Class II
- Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
- SIGMA — DEPUY (IRELAND) · Class II
Cleared under the same submission
K980545 also covers:
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
- Plasma Coated NTK System — CORIN LTD
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
- Corin Ltd
Sources (1)
- FDA UDI ce310a11-50e6-461a-ae1f-67b6c188b0d7 36 fields · synced Jun 8, 2026