510(k) K141489

LINOS MOH HAND PLATING SYSTEM by KLS Martin L.P. — Product Code HRS

K141489 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "LINOS MOH HAND PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. KLS Martin L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2014
Date Received
June 5, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type