510(k) K233721

KLS Martin Drill-Free MMF Screw by KLS-Martin L.P. — Product Code DZL

K233721 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Drill-Free MMF Screw". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
November 21, 2023
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