510(k) K240288
K240288 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 April 1, 2024. 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
- April 1, 2024
- Date Received
- February 1, 2024
- 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