Cleared Traditional

K872209 - ARTHROPLASTY MALLET
(FDA 510(k) Clearance)

K872209 · New England Surgical Instrument Corp. · General & Plastic Surgery device
Jun 1987
Decision
14d
Days
Class 1
Risk

K872209 is an FDA 510(k) clearance for the ARTHROPLASTY MALLET. This device is classified as a Mallet (Class I - General Controls, product code HXL).

Submitted by New England Surgical Instrument Corp. (Rockland, US). The FDA issued a Cleared decision on June 23, 1987, 14 days after receiving the submission on June 9, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K872209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date June 23, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HXL — Mallet
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800