LAMINOPLASY PLATING SYSTEM— 510(k) K103284

Name: FDA 510(k) clearance K103284
Creator: U.S. Food and Drug Administration
Published: 2010-12-02

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K103284 for LAMINOPLASY PLATING SYSTEM, Substantially Equivalent on 2010-12-02. Applicant: Aesculap Implant Systems, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2010-11-05
Decision date: 2010-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, 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.