Cleared Traditional

K855148 - THARIES FIBER (FDA 510(k) Clearance)

Feb 1986
Decision
54d
Days
Risk

K855148 is an FDA 510(k) clearance for the THARIES FIBER..

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 18, 1986, 54 days after receiving the submission on December 26, 1985.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K855148 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 26, 1985
Decision Date February 18, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code
Device Class