Cleared Traditional

STERNAL POWER AWL

K873766 · Bowen & Company, Inc. · Orthopedic

Nov 1988

Decision

425d

Days

Class 1

Risk

About This 510(k) Submission

K873766 is an FDA 510(k) clearance for the STERNAL POWER AWL, a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I — General Controls, product code KIJ), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on November 14, 1988, 425 days after receiving the submission on September 16, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K873766 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1987
Decision Date	November 14, 1988
Days to Decision	425 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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