Cleared Traditional

K841517 - CLOUTIER II TOTAL KNEE W/BEADED SURF (FDA 510(k) Clearance)

Aug 1984
Decision
140d
Days
Risk

K841517 is an FDA 510(k) clearance for the CLOUTIER II TOTAL KNEE W/BEADED SURF..

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1984, 140 days after receiving the submission on April 12, 1984.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K841517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1984
Decision Date August 30, 1984
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code
Device Class