BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM— 510(k) K043548

Name: FDA 510(k) clearance K043548
Creator: U.S. Food and Drug Administration
Published: 2005-06-14

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K043548 for BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM, Substantially Equivalent on 2005-06-14. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2004-12-23
Decision date: 2005-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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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.