ACE CERVICAL TRACTION HALOZS, TONGS & PINS— 510(k) K954069

Name: FDA 510(k) clearance K954069
Creator: U.S. Food and Drug Administration
Published: 1995-10-12

Substantially Equivalent

Ace Medical Co.

FDA 510(k) clearance K954069 for ACE CERVICAL TRACTION HALOZS, TONGS & PINS, Substantially Equivalent on 1995-10-12. Applicant: Ace Medical Co.. Device class: 2.

Clearance details

Applicant: Ace Medical Co.
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 1995-08-30
Decision date: 1995-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

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K954485 — 6.5MM SOLID CANCELLOUS BONE SCREW1995-10-31
K950618 — ACE SUPRACONDYLAR PLATE1995-05-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.