Cleared Traditional

MICROGUARD, ORTHOPEDIC PIN PROTECTORS

K902676 · Micro-Aire Surgical Instruments, Inc. · Orthopedic
Sep 1990
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K902676 is an FDA 510(k) clearance for the MICROGUARD, ORTHOPEDIC PIN PROTECTORS, a Fixation Accessory (Class II — Special Controls, product code LYT), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 14, 1990, 87 days after receiving the submission on June 19, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K902676 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1990
Decision Date September 14, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LYT — Fixation Accessory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030