510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063792Substantially Equivalent

Osteomed External Mandibular Distraction System

Osteomed, Addison TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063792 is the FDA 510(k) clearance record for OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM, a class II device, cleared for Osteomed LP on under FDA product code MQN (External Mandibular Fixator And/Or Distractor). FDA records list 73 510(k) clearances for Osteomed LP, from to . As of , FDA records show no recalls naming K063792.

Clearance record

Decision date
Received
(70 days to decision)
Product code
MQN External Mandibular Fixator And/Or Distractor
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Osteomed LP 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQN

Trailing 12 months

FDA records hold no clearances under product code MQN in the trailing twelve months.

FDA records show no clearances under product code MQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260