FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K Number: K020455
·
Decision Apr 3, 2002
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
14
Review Days
51
Basic Information
- Device Name
- TISSUEMEND SOFT TISSUE REPAIR MATRIX
- K Number
- K020455
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TEI BIOSCIENCES INC.
- Date Received
- February 11, 2002
- Decision Date
- April 3, 2002
- 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 TEI BIOSCIENCES INC.
| K Number | Device Name | ||
|---|---|---|---|
| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Aug 5, 2013 | Substantially Equivalent |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | Dec 10, 2010 | Substantially Equivalent |
| K083898 | SURGIMEND | Feb 4, 2009 | Substantially Equivalent |
| K083440 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Dec 12, 2008 | Substantially Equivalent |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | Aug 6, 2007 | Substantially Equivalent |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Jun 29, 2006 | Substantially Equivalent |
| K060829 | COSMATRIX | May 17, 2006 | Substantially Equivalent |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | May 17, 2006 | Substantially Equivalent |
| K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | May 15, 2006 | Substantially Equivalent |
| K051766 | ORTHOMEND | Aug 11, 2005 | Substantially Equivalent |