510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911165Substantially Equivalent

Screw, Bone, Maxillofacial

Tekno-Medical, Tarzana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911165 is the FDA 510(k) clearance record for SCREW, BONE, MAXILLOFACIAL, a class II device, cleared for Tekno-Medical on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list one 510(k) clearance for Tekno-Medical. As of , FDA records show no recalls naming K911165.

Clearance record

Decision date
Received
(158 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Tekno-Medical C/O Intl. Hospital Supply Co., Tarzana CA
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