FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MESO TENDON MATRIX
K Number: K133169
·
Decision Dec 20, 2013
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- MESO TENDON MATRIX
- K Number
- K133169
- 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
- Kensey Nash Corporation Dba Dsm Biomedical
- Date Received
- October 17, 2013
- Decision Date
- December 20, 2013
- Product Code
- OWY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kensey Nash Corporation Dba Dsm Biomedical
| K Number | Device Name | ||
|---|---|---|---|
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | May 9, 2018 | Substantially Equivalent |
| K173362 | DSM Biomedical Calcium Phosphate Cement | Apr 3, 2018 | Substantially Equivalent |
| K170245 | DSM Biomedical Dental Bone Graft | May 16, 2017 | Substantially Equivalent |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Jun 7, 2016 | Substantially Equivalent |
| K141738 | MEDEOR MATRIX WOUND DRESSING | Feb 17, 2015 | Substantially Equivalent |
| K132025 | MESO BILAYER SURGICAL MESH | Oct 30, 2013 | Substantially Equivalent |