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FDA 510(k)

ChoiceSpine Tiger Shark Cervical Spacer System

K-Number: K201643 · 2020-12-22

ApplicantChoice Spine, LLC
Decision Date2020-12-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ChoiceSpine Tiger Shark Cervical Spacer System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2020-12-22 under approval number K201643. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ChoiceSpine Tiger Shark Cervical Spacer System?

ChoiceSpine Tiger Shark Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Choice Spine, LLC. The 510(k) number is K201643.

When was ChoiceSpine Tiger Shark Cervical Spacer System approved by the FDA?

ChoiceSpine Tiger Shark Cervical Spacer System received FDA 510(k) clearance on 2020-12-22, under approval number K201643.

What company makes ChoiceSpine Tiger Shark Cervical Spacer System?

ChoiceSpine Tiger Shark Cervical Spacer System is manufactured by Choice Spine, LLC.

What is the FDA product code for ChoiceSpine Tiger Shark Cervical Spacer System?

The FDA product code for ChoiceSpine Tiger Shark Cervical Spacer System is ODP.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING

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 K211449Triton™ Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System K220953ChoiceSpine TigerShark™ M, Modular Interbody System

View all 9 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

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