Identity
- Trade Name
- S-ROM NOILES FDA UDI
- Generic Name
- Rotating hinged total knee prosthesis FDA UDI
- Device Name
- S-ROM NOILES ROTATING HINGE POSTERIOR STABILIZED TIBIAL PLATEAU CEMENTED 20mm SMALL FDA UDI
- Model / Reference
- 62-2166 FDA UDI
- Description
- S-ROM NOILES ROTATING HINGE POSTERIOR STABILIZED TIBIAL PLATEAU CEMENTED 20mm SMALL FDA UDI
Identifiers
- Catalog Number
- 622166 FDA UDI
- Primary DI / UDI-DI
- 10603295179214 FDA UDI
- 510(k) Number
- K941769 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Rotating hinged total knee 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
Category: Rotating hinged total knee prosthesis
S-Rom Noiles by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotating hinged total knee prosthesis.
- TRIATHLON — Howmedica Osteonics Corp. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- AS ENDURO — AESCULAP, INC. · Class II
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- ATTUNE LPS — DEPUY (IRELAND) · Class II
- TRIATHLON — Howmedica Osteonics Corp. · Class II
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- LEGION — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K941769 also covers:
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
- S-ROM NOILES — DEPUY ORTHOPAEDICS, INC.
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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 871fcf32-2732-4a29-98a3-e024a7887737 36 fields · synced Jun 8, 2026