510(k) K141006
- Device
- RSP HUMERAL SOCKET INSERT
- Applicant
- DJO GLOBAL
- 510(k) number
- K141006
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-05
- Date received
- 2014-04-18
- 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
- CHRISTINE CHESNUTT
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3031914485
- 3010375065
- 2245304
- 9616671
- 3004748528
- 3009923578
- 1836116
- 3006721341
- 3014004349
- 3005913274
- 1834379
- 1422572
- 3005562917
- 1020279
- 3008868758
- 1000200989
- 3007420745
- 3009888740
- 3008388276
- 3011015572
- 1226544
- 1054811
- 2030624
- 3014315560
- 3011274144
- 3000264985
- 3004641308
- 3009971621
- 1221934
- 3010163695
- 3017397663
- 3004154314
- 1000517406
- 1822565
- 3027484613
- 3014302784
- 3014833750
- 3014207283
- 8031020
- 3013194153
- 2249615
- 1529009
- 8043792
- 3016851379
- 3014680795
- 3008102042
- 3011724582
- 1450662
- 1827096
- 3013086329
- 3010314800
- 3000931034
- 3006801265
- 3021008900
- 3013176080
- 3002807310
- 3002907620
- 3002807295
- 3004153896
- 3005130928
- 1424263
- 1018470
- 3010386387
- 3015516266
- 1219655
- 3009871135
- 1043653
- 3010400367
- 3026771806
- 3014262693
- 3010178296
- 3003998208
- 3003387384
- 1644408
- 3008534770
- 3009546990
- 3010331645
- 3013014058
- 3033509898
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#
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