Cleared Traditional

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

K102743 · Ortho Solutions Limited · Orthopedic

Jan 2011

Decision

120d

Days

Class 1

Risk

About This 510(k) Submission

K102743 is an FDA 510(k) clearance for the ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Ortho Solutions Limited (Prior Lake, US). The FDA issued a Cleared decision on January 20, 2011, 120 days after receiving the submission on September 22, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K102743 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2010
Decision Date	January 20, 2011
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820