CAP BONE SUBSTITUTE MATERIAL— 510(k) K032307

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K032307 for CAP BONE SUBSTITUTE MATERIAL, Substantially Equivalent on 2003-10-24. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2003-07-25
Decision date: 2003-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.