510(k) Report

Devices descending from K012871

11 later devices reach Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+1K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+1K112493Pass LP Spinal SystemMedicrea International20111—
+1K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+2K153413PASS LP Spinal SystemMedicrea International SA20160—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501