510(k) Report

Devices descending from K153783

13 later devices reach SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223251Hexanium PLIFSpinevision, S.A.S.20220—
+1K191796Neo Cage SystemNeo Medical SA20190—
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K183092Kuros TLIF CageKuros Biosciences B.V20190—
+1K181048Neo Cage System TMNeo Medical SA20191—
+1K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K210359Hexanium TLIFSpinevision, S.A.S.20211—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—