Cleared Traditional

K151661 - Renovo Life Hard Carbon Coated Drill Bit

K151661 is an FDA 510(k) clearance for Renovo Life Hard Carbon Coated Drill Bit, manufactured by Renovo Life, LLC. The device is a Class 1 Orthopedic device with product code HTW cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K151661 · Renovo Life, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
210d
Days
Class 1
Risk

K151661 is an FDA 510(k) clearance for the Renovo Life Hard Carbon Coated Drill Bit. Classified as Bit, Drill (product code HTW), Class I - General Controls.

Submitted by Renovo Life, LLC (Belmont, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 210 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151661

510(k) Number K151661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

HTW Device Classification - Class 1, General Controls

Product Code HTW Bit, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Orgenix, LLC
Donald W Gunther

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.