Identity
- Trade Name
- S-ROM NOILES FDA UDI
- Generic Name
- Rotating hinged total knee prosthesis FDA UDI
- Device Name
- S-ROM NOILES ROTATING HINGE TIBIAL PLATEAU ASSEMBLY WITH 2 HINGE BEARINGS 16mm SMALL FDA UDI
- Model / Reference
- 62-1612 FDA UDI
- Description
- S-ROM NOILES ROTATING HINGE TIBIAL PLATEAU ASSEMBLY WITH 2 HINGE BEARINGS 16mm SMALL FDA UDI
Identifiers
- Catalog Number
- 621612 FDA UDI
- Primary DI / UDI-DI
- 10603295178972 FDA UDI
- FDA Product Code
- KRO FDA UDI
- GMDN Term
- Rotating hinged total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 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
K011810 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.
K896048 also covers:
- S-ROM NOILES — DEPUY (IRELAND)
- S-ROM NOILES — DEPUY (IRELAND)
- S-ROM NOILES — DEPUY (IRELAND)
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 7a4b9cc8-3f2d-4b45-9f9f-a7df9d889db7 36 fields · synced Jun 8, 2026