Equinoxe 301-32-09
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10885862577528 | Date13 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162726 | Date1 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 10885862577528
- FDA 510(k) database K162726
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 .
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equinoxe
- Generic name
- Orthopaedic broach
- Model / Ref / Catalog
- 301-32-09
- Primary DI / UDI-DI
- 10885862577528
- 510(k) Number
- FDA product code
- PHX, KWS, HSD, KWT
- GMDN term
- Orthopaedic broach
- Device class
- Class II
- Regulation number
- 888.3660, 888.3690, 888.3650
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Exactech, Inc.
Properties
Other properties (12)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No