Instrument 5537-T-428
Instrument 5537-T-428 is a Class II device made by Howmedica Osteonics Corp., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327247923), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613327247923 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 07613327247923
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Instrument
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / Ref / Catalog
- 5537-T-428
- Primary DI / UDI-DI
- 07613327247923
- FDA product code
- KRR, NPJ, HRY, HSX, MBH, JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3540, 888.3560, 888.3530, 888.3520, 888.3565
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Knee tibia prosthesis trial, reusable.
- Persona® 42-5892-005-12 by Zimmer, Inc.
- Persona® 42-5892-008-30 by Zimmer, Inc.
- Unity Total Knee System 1236030 by CORIN LTD
- OMNIBotics NS-5016R by OMNIlife science, Inc.
- APEX Knee System KS-94611 by OMNIlife science, Inc.
- U2 Total Knee System 2303-2402-RF by UNITED ORTHOPEDIC CORP.
- Unity Total Knee System 123.369.69 by CORIN LTD