510(k) K133169
K133169 is an FDA 510(k) premarket notification submitted by Kensey Nash Corporation Dba Dsm Biomedical for the device "MESO TENDON MATRIX". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Kensey Nash Corporation Dba Dsm Biomedical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2013
- Date Received
- October 17, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in tendon repair.