POLARIS SPINAL SYSTEM— 510(k) K103393

Name: FDA 510(k) clearance K103393
Creator: U.S. Food and Drug Administration
Published: 2011-02-02

Substantially Equivalent

Biomet Spine

FDA 510(k) clearance K103393 for POLARIS SPINAL SYSTEM, Substantially Equivalent on 2011-02-02. Applicant: Biomet Spine. Device class: 2.

Clearance details

Applicant: Biomet Spine
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2010-11-19
Decision date: 2011-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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K151224 — Lineum OCT Spine System2015-06-30
K141791 — BIOMET FUSION SYSTEM2014-10-09

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.