FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENFORM SOFT TISSUE REPAIR MATRIX
K Number: K051190
·
Decision Jun 10, 2005
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
1
Applicant Total
16
Review Days
31
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Basic Information
- Device Name
- XENFORM SOFT TISSUE REPAIR MATRIX
- K Number
- K051190
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tei Biosciences, Inc.
- Date Received
- May 10, 2005
- Decision Date
- June 10, 2005
- Product Code
- PAJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PAJ), ordered by most recent decision date.
View allOther Clearances by Tei Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Feb 16, 2017 | Substantially Equivalent |
| K153690 | PriMatrix Dermal Repair Scaffold | Feb 22, 2016 | 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 |