510(k) K150458
- Device
- Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
- Applicant
- EXACTECH, INC.
- 510(k) number
- K150458
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-14
- Date received
- 2015-02-23
- Regulation
- 888.3660
- Classification name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas McNamara
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3008812251
- 9615674
- 3007923096
- 3010386387
- 3013194153
- 3007740680
- 3006272282
- 3004748528
- 1721676
- 3011274144
- 9617840
- 1020279
- 3005061536
- 1221934
- 1219655
- 1423662
- 3008395353
- 1835572
- 3011683674
- 1043534
- 3014004349
- 1835831
- 3010163695
- 3014302784
- 3002807310
- 1424263
- 2244478
- 3005180920
- 3006017180
- 3017036078
- 3008102042
- 3004153896
- 3012818475
- 3009887475
- 3010400367
- 9616671
- 3008658204
- 3002806603
- 3011500362
- 3002808022
- 3009555440
- 3010009693
- 3003998208
- 2245304
- 3013176080
- 3000264985
- 9681465
- 3006801265
- 3011015572
- 1833506
- 1836357
- 3010314800
- 3005718816
- 3002806470
- 1818910
- 3004371426
- 3019807891
- 2029275
- 3025603301
- 3013055499
- 3009923578
- 3014262693
- 3000258338
- 3009971621
- 3006636956
- 3035366890
- 3009185591
- 3011724582
- 3014680795
- 3012544635
- 1018470
- 3007441485
- 1836116
- 8031020
- 9613350
- 3015231789
- 1649390
- 3004154314
- 3003403260
Source Documents#
Other 510(k) Records For Product Code PHX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260556 | Veritas Shoulder System | Restor3D | 2026-07-01 |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026-06-16 |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | 2026-06-12 |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | 2026-06-10 |
| 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 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 |
Legacy Summary#
summary
FDA Review#
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