510(k) Report

Devices descending from K192502

4 later devices reach Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+1K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+1K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—