Cleared Traditional

Renovo Life Hard Carbon Coated Drill Bit

K151661 · Renovo Life, LLC · Orthopedic

Jan 2016

Decision

210d

Days

Class 1

Risk

About This 510(k) Submission

K151661 is an FDA 510(k) clearance for the Renovo Life Hard Carbon Coated Drill Bit, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Renovo Life, LLC (Belmont, US). The FDA issued a Cleared decision on January 15, 2016, 210 days after receiving the submission on June 19, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K151661 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2015
Decision Date	January 15, 2016
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF