510(k) Report

Devices descending from K091725

150 later devices reach Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K182470Plateau Spacer SystemLife Spine20180—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—