Novosource Total Hip System 1280-4628
Novosource Total Hip System 1280-4628 is a Class II device made by Novosource, Inc., cleared under FDA 510(k) K140701 on 27 Jun 2014 and listed in FDA GUDID since 10 Dec 2019 (UDI-DI 00811382037467), active as of 22 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 | Number00811382037467 | Date10 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140701 | Date27 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00811382037467
- FDA 510(k) database K140701
Across registries
- FDA 510(k) K140701 decided 27 Jun 2014 Active
- FDA GUDID UDI-DI 00811382037467 listed 10 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K140701
- Listed FDA GUDID 00811382037467
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Novosource Total Hip System
- Generic name
- Constrained polyethylene acetabular liner
- Model / Ref / Catalog
- 1280-4628
- Primary DI / UDI-DI
- 00811382037467
- 510(k) Number
- FDA product code
- OQG, LPH, LZO
- GMDN term
- Constrained polyethylene acetabular liner
- Device class
- Class II
- Regulation number
- 888.3358, 888.3353
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 46 MillimeterLumen/Inner Diameter — 28 Millimeter