510(k) K091196
- Device
- GRS GLENOID RESURFACING SYSTEM
- Applicant
- ARTHROSURFACE, INC.
- 510(k) number
- K091196
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-27
- Date received
- 2009-04-23
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAWN J WILSON
- Address
- 28 Forge Pkwy. Franklin MA US 02038 02038
FDA Registration Numbers#
- 3010667733
- 3010041693
- 2183946
- 1221934
- 3025603301
- 3009475821
- 3010537287
- 3007993775
- 3016090213
- 3008812251
- 1000200989
- 3013561205
- 1043534
- 1220477
- 2245304
- 3005596372
- 3014004349
- 1220246
- 3021008900
- 3015806723
- 1833506
- 3004983210
- 3009973844
- 3006085220
- 3011189525
- 2030624
- 3004154314
- 1644408
- 1038671
- 3010400367
- 3002807295
- 3011724582
- 3020967480
- 3009116370
- 3008556682
- 1836116
- 3010039400
- 3011683674
- 3016851379
- 8010379
- 1222928
- 3010898856
- 3013700547
- 3011061242
- 3002579136
- 3014315560
- 1057425
- 1834331
- 1020279
- 1835444
- 3005130928
- 1835831
- 3010386387
- 3014252644
- 3003898228
- 3004153896
- 1422572
- 2244478
- 3015231789
- 3008337808
- 3019269298
- 1000517406
- 3012755988
- 1818910
- 3010163695
- 1649390
- 9617083
- 3011274144
- 3009941480
- 1054811
- 3003403260
- 3000264985
- 3008658204
- 3010178296
- 1643264
- 3005180920
- 3010173425
- 3015516266
- 3006128100
Source Documents#
Other 510(k) Records For Product Code KWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
Legacy Summary#
summary
FDA Review#
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