Cleared Traditional

ALIGNMENT INSTRUMENT

K970345 · Richard Wolf Medical Instruments Corp. · Orthopedic

Apr 1997

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K970345 is an FDA 510(k) clearance for the ALIGNMENT INSTRUMENT, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 29, 1997, 90 days after receiving the submission on January 29, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K970345 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1997
Decision Date	April 29, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820