510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K083432Substantially Equivalent

Drill Free Mmf Screw

KLS-Martin L.P., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083432 is the FDA 510(k) clearance record for DRILL FREE MMF SCREW, a class II device, cleared for KLS Martin L.P. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 78 510(k) clearances for KLS Martin L.P., from to . As of , FDA records show no recalls naming K083432.

Clearance record

Decision date
Received
(131 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
KLS Martin L.P. 11239 St. Johns Industrial, Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260