510(k) K181241

KLS Martin Individual Patient Solutions (IPS) Planning System by KLS-Martin L.P. — Product Code DZJ

K181241 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Individual Patient Solutions (IPS) Planning System". The FDA issued a decision of Substantially Equivalent on September 13, 2018. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2018
Date Received
May 10, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type