510(k) K230513
- Device
- Arthrex Univers Apex OptiFit Humeral Stem
- Applicant
- Arthrex, Inc.
- 510(k) number
- K230513
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-26
- Date received
- 2023-02-24
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Tiffany Mentzel
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers
- 3003403260
- 1423662
- 1450662
- 1000200989
- 3027484613
- 1833506
- 1422572
- 3004641308
- 3005180920
- 2133928
- 3009241418
- 3021566676
- 1649390
- 3006085220
- 3013176080
- 3021008900
- 3010386387
- 1043534
- 3010057495
- 3006801265
- 3008388276
- 3014252644
- 9617083
- 3009941480
- 1835831
- 3009871135
- 3015916578
- 3010537287
- 3012275107
- 1644408
- 2183946
- 1834331
- 3006721341
- 1018470
- 3010287737
- 3000264985
- 3013791180
- 3007420745
- 3014027736
- 1827096
- 3002579136
- 3015806723
- 3025603301
- 2032521
- 3005061536
- 3012818475
- 3010163695
- 1643264
- 2028632
- 3016090213
- 3026771806
- 1219655
- 3007740680
- 1721676
- 3011061242
- 3015516266
- 3009475821
- 3010041693
- 3009116370
- 3004976965
- 1064858
- 3003916006
- 9611390
- 3004153896
- 3014680795
- 3013302242
- 3031914485
- 3007923096
- 8010177
- 3009423112
- 3013014058
- 3010039400
- 9613350
- 3014262693
- 3000258338
- 2249697
- 3010331645
- 3009141957
- 3020967480
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code KWS
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|---|---|---|---|
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| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
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| 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 |
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| 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 |
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| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 |