POLI-AXIAL KNEE CAGE— 510(k) K812064

Name: FDA 510(k) clearance K812064
Creator: U.S. Food and Drug Administration
Published: 1981-08-13

Substantially Equivalent

Generation II Orthotics, Inc.

FDA 510(k) clearance K812064 for POLI-AXIAL KNEE CAGE, Substantially Equivalent on 1981-08-13. Applicant: Generation II Orthotics, Inc.. Device class: 1.

Clearance details

Applicant: Generation II Orthotics, Inc.
Product code: Code ITM
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1981-07-21
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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