CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
FDA 510(k) clearance K023096 · decided 2003-04-10
Clearance details
- K-number
- K023096
- Device name
- CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
- Applicant
- Std Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-18
- Decision date
- 2003-04-10
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- HSD
- Device class
- 2
- Regulation number
- 888.3690
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Stoughton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, recall (Z-1110-2015) | Arthrosurface, Inc. | 2015-02-12 |
| Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, recall (Z-1111-2015) | Arthrosurface, Inc. | 2015-02-12 |
| Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Par recall (Z-1112-2015) | Arthrosurface, Inc. | 2015-02-12 |
| Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part recall (Z-1113-2015) | Arthrosurface, Inc. | 2015-02-12 |
| Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-003 recall (Z-1114-2015) | Arthrosurface, Inc. | 2015-02-12 |