510(k) K031519
K031519 is an FDA 510(k) premarket notification submitted by Mitek Worldwide for the device "CUFFLOK ANCHOR". The FDA issued a decision of Substantially Equivalent on June 6, 2003. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Mitek Worldwide has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2003
- Date Received
- May 15, 2003
- Clearance Type
- Special
- 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