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

External Mandibular Fixator And/Or Distractor

21 CFR 872.4760 / Dental
FDA source (opens on fda.gov)

MQN is the FDA product code for External Mandibular Fixator And/Or Distractor, a class II device type, regulated under 21 CFR 872.4760. As of , FDA records hold 60 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
MQN
Device name
External Mandibular Fixator And/Or Distractor
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
60
Ingested recalls
9

Clearances, product code MQN

By decision year
60 clearances under product code MQN with a decision year between 1995 and 2022, 2003 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code MQN by decision year
YearClearances
19951
19964
19973
19985
19996
20004
20011
20022
20037
20044
20055
20063
20074
20083
20121
20141
20151
20161
20171
20181
20191
20221

Applicants with the most clearances

Product code MQN
Applicants holding the most 510(k) clearances under product code MQN
ApplicantClearances
Synthes (USA) Products LLC15
KLS-Martin L.P.13
Osteomed7
Biomet Microfixation6
Oral Osteodistraction, L.P.3
Howmedica Corp.2
Stryker Corp.2
Ace Surgical Supply Co., Inc.1
Zimmer GmbH1
Custom Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order