510(k) Report

Devices descending from K043185

405 later devices reach Synthes 3.5MM Cortex Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—