510(k) K243726
K243726 is an FDA 510(k) premarket notification submitted by Responsive Arthroscopy, Inc. for the device "Osprey Suture Anchor". The FDA issued a decision of Substantially Equivalent on Jan 30, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Responsive Arthroscopy, Inc. has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 2025
- Date Received
- Dec 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)