Cleared Traditional

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229

K903713 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Sep 1990

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K903713 is an FDA 510(k) clearance for the OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 14, 1990, 31 days after receiving the submission on August 14, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K903713 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 1990
Decision Date	September 14, 1990
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

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