510(k) Report

Devices descending from K161809

5 later devices reach ShurFit CpTi-HA ACIF Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—