510(k) K140300
K140300 is an FDA 510(k) premarket notification submitted by Rotation Medical, Inc. for the device "COLLAGEN TENDON SHEET-DDI (CTS-DDI)". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Rotation Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2014
- Date Received
- February 6, 2014
- 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.