510(k) Report

Devices descending from K210239

3 later devices reach CITRESPLINE and CITRELOCK ACL Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device…Acuitive Technologies, Inc.20230—
+1K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…Acuitive Technologies, Inc.20221—
+2K232592Citrelock® DuoAcuitive Technologies, Inc.20230—