FDA 510(k)

ChoiceSpine TigerShark M, Modular Interbody System

K-Number: K220953 · 2022-09-13

Decision Date2022-09-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ChoiceSpine TigerShark M, Modular Interbody System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2022-09-13 under approval number K220953. 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 ChoiceSpine TigerShark M, Modular Interbody System?

ChoiceSpine TigerShark M, Modular Interbody System is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Choice Spine, LLC. The 510(k) number is K220953.

When was ChoiceSpine TigerShark M, Modular Interbody System approved by the FDA?

ChoiceSpine TigerShark M, Modular Interbody System received FDA 510(k) clearance on 2022-09-13, under approval number K220953.

What company makes ChoiceSpine TigerShark M, Modular Interbody System?

ChoiceSpine TigerShark M, Modular Interbody System is manufactured by Choice Spine, LLC.

What is the FDA product code for ChoiceSpine TigerShark M, Modular Interbody System?

The FDA product code for ChoiceSpine TigerShark M, Modular Interbody System is MAX.

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Other Devices by Choice Spine, LLC

K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K191367Harrier-SA Lumbar Interbody System K201643ChoiceSpine Tiger Shark Cervical Spacer System K211449Triton Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL 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.