Cleared Traditional

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500

K900210 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Feb 1990

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K900210 is an FDA 510(k) clearance for the BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500, 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 February 2, 1990, 16 days after receiving the submission on January 17, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K900210 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1990
Decision Date	February 02, 1990
Days to Decision	16 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