Cleared Traditional

GRAFT HARVESTING SAWBLADES

K971978 · Wrightmedicaltechnologyinc · General & Plastic Surgery
Jun 1997
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K971978 is an FDA 510(k) clearance for the GRAFT HARVESTING SAWBLADES, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 18, 1997, 20 days after receiving the submission on May 29, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K971978 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1997
Decision Date June 18, 1997
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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