510(k) K240817
K240817 is an FDA 510(k) premarket notification submitted by Alafair Biosciences, Inc. for the device "VersaWrap". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Alafair Biosciences, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2024
- Date Received
- March 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, 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 during tendon repair procedures.