510(k) K160118
K160118 is an FDA 510(k) premarket notification submitted by Crossroads Extremity Systems, LLC for the device "STROPP (Single Tunnel Repair of Plantar Plate)". The FDA issued a decision of Substantially Equivalent on May 3, 2016. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Crossroads Extremity Systems, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2016
- Date Received
- January 19, 2016
- 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