TiGer Shark System
K-Number: K172816 · 2018-01-26
ApplicantChoicespine, LP
Decision Date2018-01-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TiGer Shark System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2018-01-26 under approval number K172816. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiGer Shark System?
TiGer Shark System is a medical device that received FDA 510(k) clearance on 2018-01-26. It is manufactured by Choicespine, LP. The 510(k) number is K172816.
When was TiGer Shark System approved by the FDA?
TiGer Shark System received FDA 510(k) clearance on 2018-01-26, under approval number K172816.
What company makes TiGer Shark System?
TiGer Shark System is manufactured by Choicespine, LP.
What is the FDA product code for TiGer Shark System?
The FDA product code for TiGer Shark System is MAX.
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: MAX)
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K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.