510(k) Report

Devices descending from K972166

11 later devices reach Guerrero - Bell Distractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026—
+1K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+1K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997—
+1K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc.19981—
+2K121502Synthes Curvilinear Distraction SystemSynthes, Inc.20121—
+2K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP20055—
+2K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP20030—
+3K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+3K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP20062—
+4K133398Stryker Pediatric Mandible DistractorStryker20141—
+5K181504Stryker Pediatric Mandibular Distractor 2Stryker20180—