ACE UNILATERAL FIXATOR II— 510(k) K936045

Name: FDA 510(k) clearance K936045
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

Ace Orthopedic Manufacturing Co.

FDA 510(k) clearance K936045 for ACE UNILATERAL FIXATOR II, Substantially Equivalent on 1994-02-22. Applicant: Ace Orthopedic Manufacturing Co.. Device class: 2.

Clearance details

Applicant: Ace Orthopedic Manufacturing Co.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-12-20
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, 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.