FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLAGEN TENDON SHEET
K Number: K112423
·
Decision Dec 22, 2011
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
5
Review Days
121
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Basic Information
- Device Name
- COLLAGEN TENDON SHEET
- K Number
- K112423
- 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
- Rotation Medical, Inc.
- Date Received
- August 23, 2011
- Decision Date
- December 22, 2011
- 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 Rotation Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Mar 26, 2014 | Substantially Equivalent |
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | Aug 29, 2013 | Substantially Equivalent |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | Jul 12, 2013 | Substantially Equivalent |
| K122048 | COLLAGEN TENDON SHEET-D | Jan 8, 2013 | Substantially Equivalent |