Choice Spine Hawkeye Vertebral Body Replacement (VBR) System— 510(k) K183588

Name: FDA 510(k) clearance K183588
Creator: U.S. Food and Drug Administration
Published: 2019-02-22

Substantially Equivalent

Choicespine

FDA 510(k) clearance K183588 for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System, Substantially Equivalent on 2019-02-22. Applicant: Choicespine. Device class: 2.

Clearance details

Applicant: Choicespine
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2018-12-21
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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K261031 — POSEIDON ST2026-07-10
K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.