510(k) K151540
K151540 is an FDA 510(k) premarket notification submitted by Eli-Ka Technologies for the device "MC BIO Supertack Tack 3mm, 4mm and 5mm". The FDA issued a decision of Substantially Equivalent on May 26, 2016. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2016
- Date Received
- June 8, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type