510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013672Substantially Equivalent

Bruges Distraction - Anchoring - Osteosynthesis System

Azary Technologies, LLC, Huntington CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013672 is the FDA 510(k) clearance record for BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM, a class II device, cleared for Azary Technologies, LLC on under FDA product code JEY (Plate, Bone). FDA records list one 510(k) clearance for Azary Technologies, LLC. As of , FDA records show no recalls naming K013672.

Clearance record

Decision date
Received
(153 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Azary Technologies, LLC P.O. Box 2156, Huntington CT
510(k) summary
Summary
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260