510(k) K955767
- Device
- COFIED MODULAR SHOULDER SYSTEM
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- 510(k) number
- K955767
- Product code
- KWS
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1996-04-08
- Date received
- 1995-12-21
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS L CRAIG
- Address
- 1450 E. Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 1000517406
- 3011724582
- 3010065126
- 1000200989
- 3002808022
- 3014272734
- 3009241418
- 3010041693
- 3009546990
- 3011061242
- 3002579136
- 3015916578
- 3012319330
- 1057425
- 8031020
- 3015542154
- 3006085220
- 3014262693
- 3013176080
- 3036756245
- 1835572
- 3017397663
- 9616680
- 1827096
- 3014680795
- 1226544
- 2245304
- 1220246
- 3010363503
- 1834331
- 1834379
- 1043534
- 1220477
- 2028632
- 1222928
- 3012275107
- 1836116
- 3003916006
- 3010383847
- 3026771806
- 2528981
- 3006946276
- 9616671
- 9617840
- 3006721341
- 3012552981
- 3000931034
- 2183946
- 3010386387
- 3012818475
- 1054811
- 3020704423
- 1020279
- 3004513872
- 3015231789
- 3010039400
- 1835444
- 3014315560
- 3006017180
- 3005718816
- 3010057495
- 3009887475
- 3031914485
- 3007420745
- 3009888740
- 3004748528
- 3011683674
- 3010287737
- 3009882462
- 3011274144
- 3007441485
- 2244478
- 1645151
- 3004371426
- 3012470322
- 3006849754
- 3004641308
- 3002907620
- 3008556682
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026-07-22 |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023-06-23 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022-07-07 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 |
Legacy Summary#
summary
FDA Review#
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