FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOTIFMESH SOFT TISSUE PATCH
K Number: K050678
·
Decision May 20, 2005
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
6
Review Days
65
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Basic Information
- Device Name
- MOTIFMESH SOFT TISSUE PATCH
- K Number
- K050678
- 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
- Proxy Biomedical , Ltd.
- Date Received
- March 16, 2005
- Decision Date
- May 20, 2005
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Proxy Biomedical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Apr 30, 2018 | Substantially Equivalent |
| K111121 | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH | May 13, 2011 | Substantially Equivalent |
| K060520 | VITAMESH MACROPOROUS PP SURGICAL MESH | Mar 28, 2006 | Substantially Equivalent |
| K052100 | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH | Aug 11, 2005 | Substantially Equivalent |
| K051245 | POLYFORM SYNTHETIC MESH | Jun 17, 2005 | Substantially Equivalent |