OSTEOPORE PCL SCAFFOLD— 510(k) K051093

Substantially Equivalent

Osteopore, Inc.

FDA 510(k) clearance K051093 for OSTEOPORE PCL SCAFFOLD, Substantially Equivalent on 2006-03-17. Applicant: Osteopore, Inc.. Device class: 2.

Clearance details

Applicant: Osteopore, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2005-04-28
Decision date: 2006-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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