Cleared Traditional

K760001 - ARCH SUPPORT (ARCH AID) (FDA 510(k) Clearance)

Jul 1976
Decision
61d
Days
Risk

K760001 is an FDA 510(k) clearance for the ARCH SUPPORT (ARCH AID)..

Submitted by Zimmer, Inc. (Walker, US). The FDA issued a Cleared decision on July 26, 1976, 61 days after receiving the submission on May 26, 1976.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K760001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1976
Decision Date July 26, 1976
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code
Device Class