HALO TRACTION CERVICAL IMMOBILIZATION— 510(k) K822885

Name: FDA 510(k) clearance K822885
Creator: U.S. Food and Drug Administration
Published: 1982-11-22

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K822885 for HALO TRACTION CERVICAL IMMOBILIZATION, Substantially Equivalent on 1982-11-22. Applicant: Orthopedic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 1982-09-28
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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