ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM— 510(k) K944092

Name: FDA 510(k) clearance K944092
Creator: U.S. Food and Drug Administration
Published: 1995-04-04

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K944092 for ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM, Substantially Equivalent on 1995-04-04. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1994-08-22
Decision date: 1995-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.