Cleared Traditional

K900926 - TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
(FDA 510(k) Clearance)

Apr 1990
Decision
55d
Days
Class 2
Risk

K900926 is an FDA 510(k) clearance for the TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS). This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 23, 1990, 55 days after receiving the submission on February 27, 1990.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K900926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 23, 1990
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code LRN — Wire, Surgical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 888.3030

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