510(k) K260294
K260294 is an FDA 510(k) premarket notification submitted by Surgical Fusion Technologies GmbH for the device "SF Push-in Anchor". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Surgical Fusion Technologies GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2026
- Date Received
- January 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type