510(k) Report

Devices descending from K792561

31 later devices reach Mini-H-Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981075Synthes (Usa) (Synthes) Single Vector Distractor with Detachable FeetSynthes (Usa)199826
+1K973018Synthes Mini Lengthening ApparatusSynthes (Usa)19972—
+1K962272Synthes Mandible DistractorSynthes (Usa)199627—
+2K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+2K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K014001Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3Oral Osteodistraction, L.P.20031—
+2K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+2K973275KLS-Martin Intraoral DistractorKLS-Martin L.P.19978—
+2K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.199717—
+3K161470Internal Distraction - SterileKLS Martin L.P.20161—
+3K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103—
+3K042066Klsa Martin Hand DistractorKLS-Martin L.P.20040—
+3K034045Oral Osteodistraction Distraction Rod Appliances, Rod 4Oral Osteodistraction, L.P.20040—
+3K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+3K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+3K991875K-L-W Intraoral DistractorKLS-Martin L.P.19993—
+3K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+3K983515KLS Intraoral Vertical DistractorKLS-Martin L.P.19983—
+3K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711—
+3K972154Cohen DistractorHowmedica Leibinger, Inc.19978—
+4K220050KLS Martin IPS DistractionKLS Martin L.P.20220—
+4K133398Stryker Pediatric Mandible DistractorStryker20141—
+4K121235Leibinger Advance Internal Midface Distraction SystemStryker20140—
+4K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+4K100833Syle SmartipOsspray, Ltd.20100—
+4K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+4K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+4K973484Chin DistractorHowmedica, Inc.19971—
+5K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—
+5K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+5K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—