510(k) K160500
K160500 is an FDA 510(k) premarket notification submitted by Ncs Lab Srl for the device "Elite SPK, Compasso, Elite SPK Kit". The FDA issued a decision of Substantially Equivalent on Apr 20, 2016. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Ncs Lab Srl has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2016
- Date Received
- Feb 23, 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
- 510(k)