A-LINK Z— 510(k) K133827

Name: FDA 510(k) clearance K133827
Creator: U.S. Food and Drug Administration
Published: 2014-11-17

Substantially Equivalent

Osteo Vasive, LLC

FDA 510(k) clearance K133827 for A-LINK Z, Substantially Equivalent on 2014-11-17. Applicant: Osteo Vasive, LLC. Device class: 2.

Clearance details

Applicant: Osteo Vasive, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-12-17
Decision date: 2014-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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 →

Recalls naming K133827

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133827.

Data sourced from openFDA. This site is unofficial and independent of the FDA.