Equinoxe 300-30-12
Equinoxe 300-30-12 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K162726 on 1 Feb 2017 and listed in FDA GUDID since 4 Apr 2017 (UDI-DI 10885862515803), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10885862515803 | Date4 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162726 | Date1 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 10885862515803
- FDA 510(k) database K162726
Across registries
- FDA 510(k) K162726 decided 1 Feb 2017 Active
- FDA GUDID UDI-DI 10885862515803 listed 4 Apr 2017 Listed
Recalls
-
- Terminated Z-0958-2019
Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
Timeline
- Cleared FDA 510(k) K162726
- Listed FDA GUDID 10885862515803
- Recall initiated FDA recalls Z-0958-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equinoxe
- Generic name
- Coated shoulder humeral stem prosthesis
- Model / Ref / Catalog
- 300-30-12
- Primary DI / UDI-DI
- 10885862515803
- 510(k) Number
- FDA product code
- KWT, HSD, KWS, PHX
- GMDN term
- Coated shoulder humeral stem prosthesis
- Device class
- Class II
- Regulation number
- 888.3650, 888.3690, 888.3660
- GUDID distribution status
- In Commercial Distribution
- Size
- Circumference — 12 MillimeterLength — 70 Millimeter