Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System— 510(k) K153107

Name: FDA 510(k) clearance K153107
Creator: U.S. Food and Drug Administration
Published: 2016-05-19

Substantially Equivalent

Choicespine, LP

FDA 510(k) clearance K153107 for Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System, Substantially Equivalent on 2016-05-19. Applicant: Choicespine, LP. Device class: 2.

Clearance details

Applicant: Choicespine, LP
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2015-10-27
Decision date: 2016-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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K190227 — Boomerang Anterior Cervical Plate System2019-05-01
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K183214 — Raven Lumbar Plate System2019-01-03
K180519 — HARRIER-SA Lumbar Interbody System2018-05-16

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.