CAP PLUS, EQUIVABONE, CAP/DBM— 510(k) K080329

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K080329 for CAP PLUS, EQUIVABONE, CAP/DBM, Substantially Equivalent on 2008-04-28. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2008-02-07
Decision date: 2008-04-28
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.