510(k) Report

Devices descending from K962272

27 later devices reach Synthes Mandible Distractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K014001Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P.20031—
+1K973275KLS-Martin Intraoral DistractorKLS-Martin L.P.19978—
+1K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.199717—
+2K161470Internal Distraction - SterileKLS Martin L.P.20161—
+2K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+2K042066Klsa Martin Hand DistractorKLS-Martin L.P.20040—
+2K034045Oral Osteodistraction Distraction Rod Appliances, Rod 4Oral Osteodistraction, L.P.20040—
+2K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+2K991875K-L-W Intraoral DistractorKLS-Martin L.P.19993—
+2K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+2K983515KLS Intraoral Vertical DistractorKLS-Martin L.P.19983—
+2K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711—
+2K972154Cohen DistractorHowmedica Leibinger, Inc.19978—
+3K220050KLS Martin IPS DistractionKLS Martin L.P.20220—
+3K133398Stryker Pediatric Mandible DistractorStryker20141—
+3K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+3K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+3K100833Syle SmartipOsspray, Ltd.20100—
+3K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+3K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+3K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+3K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+3K973484Chin DistractorHowmedica, Inc.19971—
+4K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+4K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+4K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—