510(k) K002406
K002406 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK 2GII MENISCAL REPAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 2001. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Mitek Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2001
- Date Received
- August 7, 2000
- 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