GALLERY LAMINOPLASTY FIXATION SYSTEM— 510(k) K100805

Name: FDA 510(k) clearance K100805
Creator: U.S. Food and Drug Administration
Published: 2010-07-20

Substantially Equivalent

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearance K100805 for GALLERY LAMINOPLASTY FIXATION SYSTEM, Substantially Equivalent on 2010-07-20. Applicant: Biomet Spine (Aka Ebi, LLC). Device class: 2.

Clearance details

Applicant: Biomet Spine (Aka Ebi, LLC)
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2010-03-22
Decision date: 2010-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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