ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
FDA 510(k) clearance K964215 · decided 1996-12-20
Clearance details
- K-number
- K964215
- Device name
- ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
- Applicant
- Smith & Nephew Endoscopy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-22
- Decision date
- 1996-12-20
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: recall (Z-0155-2016) | Smith & Nephew, Inc., Endoscopy Div. | 2015-10-22 |
| Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: recall (Z-0156-2016) | Smith & Nephew, Inc., Endoscopy Div. | 2015-10-22 |
| Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: recall (Z-0157-2016) | Smith & Nephew, Inc., Endoscopy Div. | 2015-10-22 |
| Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: recall (Z-0158-2016) | Smith & Nephew, Inc., Endoscopy Div. | 2015-10-22 |