510(k) Report

Devices descending from K002271

19 later devices reach 2.4MM Cortex Screw, Self-Tapping through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K011946The Spin Snap-Off ScrewNew Deal, S.A.20016—
+2K253108VEOFIX Snap Off ScrewSteps Ortho20260—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—