Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ S

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek USA, Inc

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Anatomic Peek™ Cervical Fusion System, Anatomic Peek™ Ptc Cervical Fusion System, Capstone™ Spinal System, Capstone Ptc™ Spinal System, Capstone Control™ Spinal System, Capstone Control Ptc™ Spinal System, Clydesdale™ Spinal System, Clydesdale Ptc™ S.

Pre-market Notification Details

Device IDK192502
510k NumberK192502
Device Name:Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ S
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
ContactEmmarie Halteman
CorrespondentEmmarie Halteman
Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
Subsequent Product CodeKWQ
Subsequent Product CodeMQP
Subsequent Product CodeOVD
Subsequent Product CodePLR
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-12
Decision Date2020-01-22

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