510(k) K071032
- Device
- ARTHREX UNIVERS II SHOULDER PROSTHESIS
- Applicant
- ARTHREX, INC.
- 510(k) number
- K071032
- Product code
- HSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-20
- Date received
- 2007-04-11
- Regulation
- 888.3690
- Classification name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY HOFT
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 3014262693
- 3031914485
- 9616680
- 3020967480
- 3006128100
- 2029275
- 8010379
- 3000258338
- 3006721341
- 3006563559
- 3013561205
- 2528981
- 3003898228
- 2244478
- 1526350
- 1835444
- 1423662
- 3021008900
- 3007740680
- 3010537287
- 3009973844
- 9615674
- 1836116
- 3013700547
- 3016851379
- 8010177
- 3010287737
- 3019269298
- 3012544635
- 1422572
- 3033509898
- 3010400367
- 3008110533
- 3006984710
- 3014004349
- 3007993775
- 3002907620
- 2032521
- 3026771806
- 3010331645
- 3012755988
- 3011061242
- 3004371426
- 3014207283
- 2249697
- 3021566676
- 3008868758
- 3014315560
- 2028632
- 2245304
- 1644408
- 3008337808
- 3012470322
- 1018470
- 1064858
- 3008556682
- 9617083
- 9616671
- 8043792
- 3014680795
- 1057425
- 1818910
- 1836357
- 3000264985
- 3014833750
- 3009475821
- 3005913274
- 1220477
- 3005061536
- 3009888740
- 3015231789
- 3005144609
- 3010041693
- 3003998208
- 3008021110
- 3010047402
- 9616944
- 3005180920
- 3010375065
Source Documents#
Other 510(k) Records For Product Code HSD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | 2024-02-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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