510(k) K250021
K250021 is an FDA 510(k) premarket notification submitted by Nanofiber Solutions, LLC for the device "Rotium". The FDA issued a decision of Substantially Equivalent on February 27, 2025. The device falls under product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. Nanofiber Solutions, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2025
- Date Received
- January 3, 2025
- 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.