Panels › Orthopedic › Product code QHE · Class 2
Shoulder Arthroplasty Implantation System
Regulation 888.3660
4510(k)s in 12 months (26 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in QHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Materialise NV | 9 | 0 |
| Orthosoft Inc (D/B/A Zimmer Cas) | 6 | 0 |
| Arthrex, Inc. | 3 | 0 |
| Precision AI Pty, Ltd. | 3 | 0 |
| LinkBio Corp. | 1 | 1 |
| Techmah Medical, LLC | 2 | 0 |
| 3D-Side | 1 | 0 |
| Lima Corporate S.P.A. | 1 | 0 |
| Tornier S.A.S. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | Linkbio Corp. LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. Open, Classified |
QHE | K241470 |
| Jun 25, 2021 | Tornier S.A.S. The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only:
a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr,
b) Catalog # DWH041 - Dia Open, Classified |
QHE | None listed |
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