BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE— 510(k) K081849

Name: FDA 510(k) clearance K081849
Creator: U.S. Food and Drug Administration
Published: 2008-08-28

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K081849 for BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE, Substantially Equivalent on 2008-08-28. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2008-06-30
Decision date: 2008-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Wayne, NJ, 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.