510(k) K214001
- Device
- Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
- Applicant
- Biomet Manufacturing Corp
- 510(k) number
- K214001
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-15
- Date received
- 2021-12-21
- 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
- Aishwarya Pandey
- Address
- 56 E. Bell Dr. Warsaw IN US 46582 46582
FDA Registration Numbers#
- 3014262693
- 3031914485
- 9616680
- 3020967480
- 2029275
- 8010379
- 3000258338
- 3006721341
- 3006563559
- 3013561205
- 2528981
- 3003898228
- 2244478
- 1835444
- 1423662
- 3021008900
- 3009532798
- 3013194153
- 3007740680
- 9615674
- 1836116
- 3016851379
- 3010287737
- 3019269298
- 3012544635
- 1422572
- 3033509898
- 3014128390
- 3010400367
- 3008110533
- 3006984710
- 3005562917
- 3014004349
- 3002907620
- 3009971621
- 3026771806
- 3010331645
- 1043653
- 3004371426
- 3014207283
- 2249697
- 3008868758
- 3014315560
- 1644408
- 2245304
- 3008337808
- 3012470322
- 1018470
- 3033273230
- 9616671
- 8043792
- 3014680795
- 3006636956
- 1818910
- 1836357
- 3000264985
- 3014833750
- 3009475821
- 3005913274
- 1220477
- 3005061536
- 3009888740
- 3015231789
- 3006001176
- 3003998208
- 3008021110
- 3010047402
- 9616944
- 3005180920
- 3010375065
- 3006272282
- 3029890418
- 1020279
- 3004983210
- 3011015572
- 1825034
- 2183946
- 3002806470
- 1226544
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 |