Identity
- Trade Name
- SIGMA FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Device Name
- SIGMA FEMORAL CRUCIATE RETAINING POROCOAT SIZE 1.5 LEFT FDA UDI
- Model / Reference
- 94-0017 FDA UDI
- Description
- SIGMA FEMORAL CRUCIATE RETAINING POROCOAT SIZE 1.5 LEFT FDA UDI
Identifiers
- Catalog Number
- 940017 FDA UDI
- Primary DI / UDI-DI
- 10603295223436 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDI
- GMDN Term
- Coated knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
MR Conditional FDA UDI
Category: Coated knee femur prosthesis
Sigma by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee femur prosthesis.
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- Persona® PPS® — Zimmer, Inc. · Class II
- Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
- APEX PS Knee — OMNIlife science, Inc. · Class II
Cleared under the same submission
K062654 also covers:
K241000 also covers:
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- ATTUNE — DEPUY (IRELAND)
- P.F.C. — DEPUY (IRELAND)
- P.F.C. — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
- P.F.C. SIGMA — DEPUY (IRELAND)
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
- Depuy (ireland)
Sources (1)
- FDA UDI a7d7819c-5eca-4ffb-be7a-b2c080cc8f5b 36 fields · synced Jun 8, 2026