Renovo Life Hard Carbon Coated Drill Bit— 510(k) K151661

Name: FDA 510(k) clearance K151661
Creator: U.S. Food and Drug Administration
Published: 2016-01-15

Substantially Equivalent

Renovo Life, LLC

FDA 510(k) clearance K151661 for Renovo Life Hard Carbon Coated Drill Bit, Substantially Equivalent on 2016-01-15. Applicant: Renovo Life, LLC. Device class: 1.

Clearance details

Applicant: Renovo Life, LLC
Product code: Code HTW
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 2015-06-19
Decision date: 2016-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belmont, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTW

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K942906 — AGEE-WRISTJACK PRE-DRILL KIT1994-12-22
K930339 — REAMER BIT1993-08-06
K915692 — CANNULATED DRILL BIT1992-01-16
K892903 — MITEK ANCHOR DRILL1989-10-06
K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS1987-02-06

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Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.