510(k) Report

Devices descending from P970013

32 later devices reach Microny Pacemakers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090048Asfora Bullet Cage SystemMedical Designs, LLC200931—
+2K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K112648Asfora Bullet CageMedical Designs, LLC201214—
+2K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+3K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K172756Varian cageMedyssey USA, Inc.20171—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—