Identity
- Trade Name
- MRS FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Device Name
- Tibial Module Stem Section FDA UDI
- Model / Reference
- 6485-6-509 FDA UDI
- Description
- Tibial Module Stem Section FDA UDI
Identifiers
- Catalog Number
- 6485-6-509 FDA UDI
- Primary DI / UDI-DI
- 07613327048643 FDA UDI
- 510(k) Number
- K952970 FDA UDI
- FDA Product Code
- KRO FDA UDIJDI FDA UDI
- GMDN Term
- Coated knee tibia prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3350 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 127.0 Millimeter FDA UDI
Category: Coated knee tibia prosthesis
Mrs by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee tibia prosthesis.
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
- OMNI Knee — OMNIlife science, Inc. · Class II
- Columbus® CR/PS — AESCULAP, INC. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K952970 also covers:
- Kinematic — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
- MRS — Howmedica Osteonics Corp.
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 8f1e16a6-b710-442d-b243-6f2289d8b02a 36 fields · synced May 30, 2026