LAMINOPLASTY PLATING SYSTEM— 510(k) K090354

Name: FDA 510(k) clearance K090354
Creator: U.S. Food and Drug Administration
Published: 2009-05-12

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K090354 for LAMINOPLASTY PLATING SYSTEM, Substantially Equivalent on 2009-05-12. Applicant: Aesculap Implant System, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2009-02-11
Decision date: 2009-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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