Cleared Special

K072706 - MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
(FDA 510(k) Clearance)

K072706 · Conmed Linvatec · Orthopedic

Oct 2007

Decision

30d

Days

Class 2

Risk

K072706 is an FDA 510(k) clearance for the MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on October 24, 2007, 30 days after receiving the submission on September 24, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K072706 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2007
Decision Date	October 24, 2007
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).