Cleared Traditional

BIOABSORBABLE BANKART TACK

K973849 · Hogan & Hartson · Orthopedic
Jan 1998
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K973849 is an FDA 510(k) clearance for the BIOABSORBABLE BANKART TACK, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on January 6, 1998, 90 days after receiving the submission on October 8, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K973849 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1997
Decision Date January 06, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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