510(k) K003324
- Device
- PLASMA SPRAYED SHOULDER
- Applicant
- ENCORE ORTHOPEDICS, INC.
- 510(k) number
- K003324
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-06
- Date received
- 2000-10-24
- 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
- JOANNA DROEGE
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3000931034
- 3006946276
- 3004983210
- 3007366790
- 3010178296
- 3008868758
- 1828464
- 3014027736
- 3009555440
- 3000264985
- 1649390
- 1825034
- 1833506
- 1833986
- 1423662
- 3008658204
- 3010009693
- 3012275107
- 9613350
- 1450662
- 3006721341
- 1221934
- 3004976965
- 3007740680
- 3014252644
- 1836116
- 3009153862
- 1827096
- 3005144609
- 3006801265
- 3036756245
- 3009241418
- 1643264
- 3005596372
- 2244478
- 1822565
- 3006128100
- 3015806723
- 1000517406
- 3013561205
- 3013055499
- 3025603301
- 3002579136
- 3007420745
- 3013700547
- 1721676
- 3010383847
- 3009888740
- 3027484613
- 3002808022
- 3013086329
- 3035366890
- 3010163695
- 9615674
- 1834379
- 1222928
- 3012818475
- 1649518
- 3011189525
- 3006356043
- 1226544
- 3019269298
- 3003916006
- 3010065126
- 3010057495
- 3000258338
- 3002806470
- 3008337808
- 3010173425
- 3003403260
- 3014302784
- 3011274144
- 3006017180
- 1018470
- 3009973844
- 9616944
- 3011061242
- 3016851379
- 1644408
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#
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FDA Review#
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