510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993869Substantially Equivalent

Inter-Os Bone Generator

Inter-Os Technologies, Aurora CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993869 is the FDA 510(k) clearance record for INTER-OS BONE GENERATOR, a class II device, cleared for Inter-Os Technologies, LLC on under FDA product code MQN (External Mandibular Fixator And/Or Distractor). FDA records list 2 510(k) clearances for Inter-Os Technologies, LLC, from to . As of , FDA records show no recalls naming K993869.

Clearance record

Decision date
Received
(65 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
Inter-Os Technologies, LLC 7144 S. Chapparal Cir. E., Aurora CO
510(k) summary
Summary
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