510(k) Report

Devices descending from K930834

219 later devices reach Acutract through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+11K252088Firebird SI Navigation SystemOrthofix US, LLC20251—