510(k) Report

Devices descending from K042143

6 later devices reach Excella-M Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+1K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+2K162143FixxSure® X-LinkInnovasis, Inc.20160—
+2K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501