Tomcat Cervical Spinal System
K-Number: K170953 · 2017-04-21
ApplicantChoicespine, LP
Decision Date2017-04-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tomcat Cervical Spinal System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2017-04-21 under approval number K170953. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tomcat Cervical Spinal System?
Tomcat Cervical Spinal System is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Choicespine, LP. The 510(k) number is K170953.
When was Tomcat Cervical Spinal System approved by the FDA?
Tomcat Cervical Spinal System received FDA 510(k) clearance on 2017-04-21, under approval number K170953.
What company makes Tomcat Cervical Spinal System?
Tomcat Cervical Spinal System is manufactured by Choicespine, LP.
What is the FDA product code for Tomcat Cervical Spinal System?
The FDA product code for Tomcat Cervical Spinal System is OVE.
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Other Devices by Choicespine, LP
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)
K160775Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
K153107Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K171489Acapella Cervical Spacer System
K170821ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System
K170942The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
Related Devices (Code: OVE)
K162531STERISPINE CCSafe Orthopaedics
K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.
K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC
K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated
K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation
K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.