BLAKSTONE LAMINOPLASTY FIXATION SYSTEM— 510(k) K043338

Name: FDA 510(k) clearance K043338
Creator: U.S. Food and Drug Administration
Published: 2005-02-18

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K043338 for BLAKSTONE LAMINOPLASTY FIXATION SYSTEM, Substantially Equivalent on 2005-02-18. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2004-12-03
Decision date: 2005-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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