510(k) Report

Devices descending from K233944

3 later devices reach CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+1K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—