FDA Product Code MQN: External Mandibular Fixator And/or Distractor
Leading manufacturers include KLS-Martin L.P..
60
Total
60
Cleared
119d
Avg days
1995
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared External Mandibular Fixator And/or Distractor Devices (Product Code MQN)
60 devices
About Product Code MQN - Regulatory Context
510(k) Submission Activity
60 total 510(k) submissions under product code MQN since 1995, with 60 receiving FDA clearance (average review time: 119 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MQN devices are reviewed by the Dental panel. Browse all Dental devices →