Cleared Traditional

STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS

K863734 · Micro-Aire Surgical Instruments, Inc. · Orthopedic
Oct 1986
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K863734 is an FDA 510(k) clearance for the STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on October 20, 1986, 27 days after receiving the submission on September 23, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K863734 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1986
Decision Date October 20, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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