510(k) K012465
K012465 is an FDA 510(k) premarket notification submitted by Bonutti Research, Inc. for the device "MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR". The FDA issued a decision of Substantially Equivalent on October 29, 2001. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Bonutti Research, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2001
- Date Received
- August 1, 2001
- 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