FDA 510(k)

KLS Martin IPS Distraction

Número K: K220050 · 2022-08-11

Data da decisão2022-08-11

Código do produtoMQN

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

KLS Martin IPS Distraction is the device name listed in this FDA 510(k) record. The listed applicant is KLS Martin L.P.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K220050. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KLS Martin IPS Distraction?

KLS Martin IPS Distraction is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is KLS Martin L.P.. The 510(k) number is K220050.

When did KLS Martin IPS Distraction receive FDA 510(k) clearance?

KLS Martin IPS Distraction received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220050.

Who is the listed applicant for KLS Martin IPS Distraction?

The FDA 510(k) record lists KLS Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin IPS Distraction?

The FDA product code for KLS Martin IPS Distraction is MQN.

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Outros registros que listam KLS Martin L.P. como candidato(a)

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions K254162KLS Martin Ixos System K253660KLS Martin Pure Pectus System K250988KLS Martin Pure Pectus System K250865KLS Martin IPS Forearm System K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Ver todos os 33 dispositivos →

Dispositivos Relacionados (Código: MQN)

K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC K181504Stryker Pediatric Mandibular Distractor 2Stryker K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC K161470Internal Distraction - SterileKLS Martin L.P.

Fonte oficial

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