510(k) Report

Devices descending from K062132

243 later devices reach Avs PL Peek Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—