510(k) K023096 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
| Applicant | Std Mfg., Inc., Stoughton MA, US |
| Decision | Substantially Equivalent, Apr 10, 2003 |
| Received | Sep 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoul Terminated |
HSD | None listed |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shou Terminated |
HSD | None listed |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulde Terminated |
HSD | None listed |
| Feb 12, 2015 | Arthrosurface, Inc. Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic should Terminated |
HSD | None listed |
| Feb 12, 2015 | Arthrosurface, Inc. Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic sh Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.