FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIMMER COLLAGEN REPAIR PATCH
K Number: K053562
·
Decision Jun 23, 2006
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
6
Review Days
184
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Basic Information
- Device Name
- ZIMMER COLLAGEN REPAIR PATCH
- K Number
- K053562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tissue Science Laboratories, Plc
- Date Received
- December 21, 2005
- Decision Date
- June 23, 2006
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Tissue Science Laboratories, Plc
| K Number | Device Name | ||
|---|---|---|---|
| K050355 | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 | Mar 9, 2005 | Substantially Equivalent |
| K043366 | PERMACOL SURGICAL IMPLANT | Dec 17, 2004 | Substantially Equivalent |
| K021056 | PERMACOL | Oct 31, 2002 | Substantially Equivalent |
| K013625 | PERMACOL | Jan 17, 2002 | Substantially Equivalent |
| K992556 | PERMACOL | Feb 17, 2000 | Substantially Equivalent |