Equinoxe 300-50-45
Equinoxe 300-50-45 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K121067 on 6 Dec 2012 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862210807), 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 | Number10885862210807 | Date30 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121067 | Date6 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 10885862210807
- FDA 510(k) database K121067
Across registries
- FDA 510(k) K121067 decided 6 Dec 2012 Active
- FDA GUDID UDI-DI 10885862210807 listed 30 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K121067
- Listed FDA GUDID 10885862210807
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equinoxe
- Generic name
- Shoulder humeral body prosthesis
- Model / Ref / Catalog
- 300-50-45
- Primary DI / UDI-DI
- 10885862210807
- 510(k) Number
- FDA product code
- KWS, KWT, HSD
- GMDN term
- Shoulder humeral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650, 888.3690
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Shoulder humeral body prosthesis.