510(k) K241018

KLS Martin Orthopedic Implants - MR Conditional by KLS-Martin L.P. — Product Code HRS

K241018 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Orthopedic Implants - MR Conditional". The FDA issued a decision of Substantially Equivalent on July 12, 2024. 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 12, 2024
Date Received
April 15, 2024
Clearance Type
Traditional
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