OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT— 510(k) K072601

Name: FDA 510(k) clearance K072601
Creator: U.S. Food and Drug Administration
Published: 2007-12-10

Substantially Equivalent

Osteosymbionics, LLC

FDA 510(k) clearance K072601 for OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT, Substantially Equivalent on 2007-12-10. Applicant: Osteosymbionics, LLC. Device class: 2.

Clearance details

Applicant: Osteosymbionics, LLC
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2007-09-14
Decision date: 2007-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.