ACE FISCHER EXTERNAL FIXATION DEVICE— 510(k) K801594

Name: FDA 510(k) clearance K801594
Creator: U.S. Food and Drug Administration
Published: 1980-09-09

Substantially Equivalent

Ace Orthopedic Manufacturing Co.

FDA 510(k) clearance K801594 for ACE FISCHER EXTERNAL FIXATION DEVICE, Substantially Equivalent on 1980-09-09. Applicant: Ace Orthopedic Manufacturing Co.. Device class: 1.

Clearance details

Applicant: Ace Orthopedic Manufacturing Co.
Product code: Code HXK
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1980-07-14
Decision date: 1980-09-09
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.