510(k) K131231
- Device
- AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
- Applicant
- Tornier SAS
- 510(k) number
- K131231
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-16
- Date received
- 2013-04-30
- 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
- No
Applicant Contact#
- Contact
- SEVERINE BONNETON
- Address
- 161 Rue Lavoisier Montbonnot-Saint-Martin FR 38330 38330
FDA Registration Numbers#
- 1221934
- 3010314800
- 1835831
- 3010331645
- 3015806723
- 3010370880
- 1836357
- 1828464
- 1526534
- 1818910
- 3002806603
- 2528981
- 1000517406
- 3008337808
- 3008388276
- 1721676
- 3006636956
- 3011015572
- 3008421730
- 1424263
- 3004748528
- 9681465
- 3004371426
- 9616671
- 1836116
- 2249615
- 3002806470
- 3003403260
- 3014833750
- 9616680
- 1220246
- 3033509898
- 1822565
- 3012552981
- 3006946276
- 3006272282
- 1825034
- 3006721341
- 3010178296
- 1834379
- 3006001176
- 3014262693
- 3007420745
- 3007740680
- 3016851379
- 3000258338
- 3009732568
- 3011943495
- 3007923096
- 1054811
- 1038671
- 3035366890
- 1220477
- 3008534770
- 3029890418
- 3015516266
- 3000264985
- 3013561205
- 3014315560
- 3000931034
- 2245304
- 3009941480
- 3005913274
- 3014128390
- 3009475821
- 3012818475
- 3015231789
- 1649518
- 3015542154
- 3012544635
- 3013194153
- 3008812251
- 1827096
- 3014004349
- 3009923578
- 1423662
- 1000200989
- 3021008900
- 3009532798
- 3010047402
Source Documents#
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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases