510(k) Report

Devices descending from K162918

29 later devices reach Atlas Spine Expandable Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+1K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+2K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+2K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—