510(k) K220050

KLS Martin IPS Distraction by KLS Martin L.P. — Product Code MQN

K220050 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin IPS Distraction". The FDA issued a decision of Substantially Equivalent on August 11, 2022. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. KLS Martin L.P. has at least 10 other 510(k) clearances on record.