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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 the device name listed in this FDA 510(k) record. The listed applicant is Choice Spine, LLC. It received FDA 510(k) clearance on 2020-12-22 under 510(k) 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. The listed applicant is Choice Spine, LLC. The 510(k) number is K201643.

When did ChoiceSpine Tiger Shark Cervical Spacer System receive FDA 510(k) clearance?

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

Who is the listed applicant for ChoiceSpine Tiger Shark Cervical Spacer System?

The FDA 510(k) record lists Choice Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Choice Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemK220953ChoiceSpine TigerShark™ M, Modular Interbody SystemK220024ChoiceSpine Navigation SystemK211449Triton™ Sacroiliac Joint Fixation SystemK203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemK203561ChoiceSpine Navigation System

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.

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