Cleared Traditional

A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS

K904949 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Nov 1990

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K904949 is an FDA 510(k) clearance for the A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS, 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 November 26, 1990, 24 days after receiving the submission on November 2, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K904949 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1990
Decision Date	November 26, 1990
Days to Decision	24 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