510(k) Report

Devices descending from K993067

111 later devices reach Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—