ChoiceSpine Tiger Shark Cervical Spacer System— 510(k) K201643

Name: FDA 510(k) clearance K201643
Creator: U.S. Food and Drug Administration
Published: 2020-12-22

Substantially Equivalent

Choice Spine, LLC

FDA 510(k) clearance K201643 for ChoiceSpine Tiger Shark Cervical Spacer System, Substantially Equivalent on 2020-12-22. Applicant: Choice Spine, LLC. Device class: 2.

Clearance details

Applicant: Choice Spine, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-06-17
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Choice Spine, LLC

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K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System2023-09-14
K220953 — ChoiceSpine TigerShark M, Modular Interbody System2022-09-13
K220024 — ChoiceSpine Navigation System2022-07-06
K211449 — Triton Sacroiliac Joint Fixation System2021-08-31
K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer System2021-05-10

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.