510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060138Substantially Equivalent

Synthes (USA) Craniomaxillofacial Distraction System

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060138 is the FDA 510(k) clearance record for SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code MQN (External Mandibular Fixator And/Or Distractor). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 2 recalls naming K060138.

Clearance record

Decision date
Received
(134 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
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
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