510(k) K223833
- Device
- Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
- Applicant
- Exactech, Inc.
- 510(k) number
- K223833
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-14
- Date received
- 2022-12-22
- Regulation
- 888.3660
- Classification name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Liz Howell
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 10885862593887 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862594006 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593993 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593986 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593979 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593962 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593955 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593948 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593931 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593924 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593917 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593900 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593894 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862594013 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593870 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593863 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593856 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593849 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593832 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593825 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593818 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593801 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593795 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593788 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593771 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862593764 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862622471 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862622594 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862622587 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
| 10885862622570 | Equinoxe® | Exactech, Inc. | 2023-11-28 |
Other 510(k) Records For Product Code PHX
| 510(k) | Device | Applicant | Decision date |
|---|
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026-05-07 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026-04-14 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 |
| K253624 | INHANCE Reverse Shoulder System | Depuy Ireland UC | 2026-03-11 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026-01-22 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026-01-08 |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025-10-31 |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025-10-29 |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025-09-26 |