ORTHOFIX AXIALEXTERNAL FIXATION SYS.— 510(k) K802814

Name: FDA 510(k) clearance K802814
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Cintor Orthopaedic Div.

FDA 510(k) clearance K802814 for ORTHOFIX AXIALEXTERNAL FIXATION SYS., Substantially Equivalent on 1980-12-10. Applicant: Cintor Orthopaedic Div.. Device class: 2.

Clearance details

Applicant: Cintor Orthopaedic Div.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1980-11-07
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.