K820719Substantially Equivalent

The Icr Knee

Name: K820719 The Icr Knee
Creator: American Ortomed Corp.
Published: 1982-05-12
License: https://open.fda.gov/license/

American Ortomed Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K820719 is the FDA 510(k) clearance record for THE ICR KNEE, cleared for American Ortomed Corp. on 1982-05-12. FDA records list 6 510(k) clearances for American Ortomed Corp., from 1978-06-14 to 1985-01-30. As of 2026-09-10, FDA records show no recalls naming K820719.

Clearance record

Decision date: 1982-05-12
Received: 1982-03-16 (57 days to decision)
Review panel: Unknown
Applicant: American Ortomed Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No