510(k) Report

Devices descending from DEN200035

2 later devices reach BEAR (Bridge-Enhanced ACL Repair) Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243578BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc.202512
+2K251214BEAR® (Bridge-Enhanced ACL Restoration) ImplantMiach Orthopaedics, Inc.20260—