510(k) K181420
- Device
- Aequalis Flex Revive Shoulder System
- Applicant
- Tornier, Inc.
- 510(k) number
- K181420
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-20
- Date received
- 2018-05-31
- 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
- Laurie Lewandowski
- Address
- 10801 Nesbitt Ave. S. Bloomington MN US 55437 55437
FDA Registration Numbers#
- 3008812251
- 3012755988
- 9615674
- 3007923096
- 3010386387
- 3007740680
- 3004748528
- 1721676
- 3011274144
- 9617840
- 1020279
- 3005061536
- 1221934
- 1219655
- 1423662
- 3008395353
- 1835572
- 3011683674
- 3009141957
- 1043534
- 3014004349
- 3021566676
- 1835831
- 3010163695
- 3014302784
- 3009973844
- 3002807310
- 1424263
- 2244478
- 3005180920
- 3010041693
- 3006017180
- 3017036078
- 3004153896
- 3012818475
- 1057425
- 2032521
- 3007993775
- 3010383847
- 3009887475
- 3013700547
- 3010400367
- 9616671
- 3008658204
- 3002806603
- 3002808022
- 3011061242
- 3009555440
- 3010009693
- 3003998208
- 2245304
- 3007539489
- 3013176080
- 3000264985
- 9681465
- 3006801265
- 8031020
- 3011015572
- 3009882462
- 3006946276
- 3016090213
- 1836357
- 3010314800
- 1833506
- 3005718816
- 3012319330
- 3002806470
- 1818910
- 3004371426
- 3014272734
- 3019807891
- 2029275
- 3025603301
- 3013055499
- 3003477135
- 1833986
- 3014262693
- 3006085220
- 3000258338
Source Documents#
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases