FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PriMatrix Dermal Repair Scaffold
K Number: K153690
·
Decision Feb 22, 2016
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
16
Review Days
61
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Basic Information
- Device Name
- PriMatrix Dermal Repair Scaffold
- K Number
- K153690
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tei Biosciences, Inc.
- Date Received
- December 23, 2015
- Decision Date
- February 22, 2016
- Product Code
- KGN
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Tei Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Feb 16, 2017 | Substantially Equivalent |
| 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 |