510(k) Report

Devices descending from K033901

737 later devices reach Merlin Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—