510(k) K233260
- Device
- Univers Revers CA Head and Adapter
- Applicant
- Arthrex, Inc.
- 510(k) number
- K233260
- Product code
- HSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-12
- Date received
- 2023-09-29
- Regulation
- 888.3690
- Classification name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ivette Galmez
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3008812251
- 3010041993
- 3012755988
- 9615674
- 3007923096
- 3010386387
- 3013194153
- 3007740680
- 3004748528
- 1721676
- 3015399803
- 3011274144
- 9617840
- 1020279
- 3005061536
- 1649379
- 1221934
- 1423662
- 3008395353
- 1835572
- 3011683674
- 3009141957
- 1043534
- 3014004349
- 3021566676
- 1835831
- 3010163695
- 3014302784
- 3002807310
- 1424263
- 2244478
- 3005180920
- 3010041693
- 3006017180
- 3008102042
- 3004153896
- 3012818475
- 3009173317
- 1057425
- 2032521
- 3010383847
- 3009887475
- 3013700547
- 9614209
- 3010400367
- 9616671
- 3008658204
- 3002806603
- 3011500362
- 3002808022
- 3011061242
- 1649833
- 3010009693
- 2245304
- 3007539489
- 3013176080
- 3020162561
- 3000264985
- 9681465
- 3006801265
- 3009973505
- 3011015572
- 3009882462
- 1833506
- 3010314800
- 3012319330
- 3002806470
- 1818910
- 3004371426
- 3003639920
- 2032098
- 2029275
- 3025603301
- 3013055499
- 3003477135
- 1833986
- 3014262693
- 3006085220
- 3000258338
- 9614841
Source Documents#
Other 510(k) Records For Product Code HSD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022-05-19 |
| K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020-11-12 |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | 2020-05-15 |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018-04-18 |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016-11-21 |
| K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016-11-01 |
| K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016-04-19 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | 2014-12-19 |
| K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | Exactech, Inc. | 2013-11-26 |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Fx Solutions | 2013-11-09 |
| K130675 | ARTHREX UNIVERS II CA HEADS | Arthrex, Inc. | 2013-10-30 |
| K130635 | SEVIIN SURFACE REPLACEMENT SHOULDER | Ingen Orthopedics, LLC | 2013-08-26 |
| K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | Smith & Nephew, Inc. | 2012-09-07 |
| K112900 | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | Lima Corporate S.P.A. | 2012-06-01 |
| K112983 | SPACER-S | Tecres S.P.A. | 2011-12-12 |