Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)— 510(k) K162103

Name: FDA 510(k) clearance K162103
Creator: U.S. Food and Drug Administration
Published: 2016-11-23

Substantially Equivalent

Choicespine, LP

FDA 510(k) clearance K162103 for Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye), Substantially Equivalent on 2016-11-23. 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: 2016-07-29
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
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.