Cleared Traditional

ACUMED BONE GRAFT SYSTEM

K960711 · Acu Med, Inc. · Orthopedic

May 1996

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K960711 is an FDA 510(k) clearance for the ACUMED BONE GRAFT SYSTEM, a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I — General Controls, product code KIJ), submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on May 7, 1996, 76 days after receiving the submission on February 21, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K960711 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1996
Decision Date	May 07, 1996
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820