Oss Bowed Collared Stem Trial 110018735
Oss Bowed Collared Stem Trial 110018735 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K141331 on 27 Oct 2014 and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00880304679207), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304679207 | Date27 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141331 | Date27 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 00880304679207
- FDA 510(k) database K141331
Across registries
- FDA 510(k) K141331 decided 27 Oct 2014 Active
- FDA GUDID UDI-DI 00880304679207 listed 27 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K141331
- Listed FDA GUDID 00880304679207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Oss Bowed Collared Stem Trial
- Generic name
- Knee femur prosthesis trial, reusable
- Model / Ref / Catalog
- 110018735
- Primary DI / UDI-DI
- 00880304679207
- 510(k) Number
- FDA product code
- KRO, LPH, JDI
- GMDN term
- Knee femur prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3510, 888.3358, 888.3350
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Knee femur prosthesis trial, reusable.