510(k) Report

Devices descending from K210497

39 later devices reach SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+1K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+1K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+1K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+1K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+1K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+2K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+2K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+2K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+2K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+2K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+2K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—