510(k) K901273

L.M.S. SELF-DETACHABLE BROACH WITH STOP by Med-Tek Corp. — Product Code HTY

K901273 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "L.M.S. SELF-DETACHABLE BROACH WITH STOP". The FDA issued a decision of Substantially Equivalent on June 5, 1990. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Med-Tek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1990
Date Received
March 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type