FIXXSURE CROSS LINK— 510(k) K081331

Name: FDA 510(k) clearance K081331
Creator: U.S. Food and Drug Administration
Published: 2008-07-23

Substantially Equivalent

Spineworks, LLC

FDA 510(k) clearance K081331 for FIXXSURE CROSS LINK, Substantially Equivalent on 2008-07-23. Applicant: Spineworks, LLC. Device class: 2.

Clearance details

Applicant: Spineworks, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-05-12
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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K133340 — SPINEWORKS ANTERIOR LUMBAR DEVICE2014-04-11
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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.