VISUALIF CHALLENGING ACCESS PLATE— 510(k) K122168

Name: FDA 510(k) clearance K122168
Creator: U.S. Food and Drug Administration
Published: 2012-10-11

Substantially Equivalent

Spine Smith Partners L.P.

FDA 510(k) clearance K122168 for VISUALIF CHALLENGING ACCESS PLATE, Substantially Equivalent on 2012-10-11. Applicant: Spine Smith Partners L.P.. Device class: 2.

Clearance details

Applicant: Spine Smith Partners L.P.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2012-07-23
Decision date: 2012-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, 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 →

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