510(k) K151983
K151983 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin LSS Plating System". The FDA issued a decision of Substantially Equivalent on April 6, 2016. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. KLS Martin L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2016
- Date Received
- July 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type