510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K072463Substantially Equivalent

Satyrne Interflex Mandibular Fixation System

Satyrne Medical, Albuquerque NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072463 is the FDA 510(k) clearance record for SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM, a class II device, cleared for Satyrne Medical on under FDA product code JEY (Plate, Bone). FDA records list one 510(k) clearance for Satyrne Medical. As of , FDA records show no recalls naming K072463.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Satyrne Medical 1909 Gold Ave. SE # 1, Albuquerque NM
510(k) summary
Summary PDF
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