510(k) K953560
K953560 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "MITEK THREADED ANCHOR (FASTIN)". The FDA issued a decision of SN on January 31, 1996. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- January 31, 1996
- Date Received
- July 20, 1995
- 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