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

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.

Clearance details

Applicant: Renovo Life, LLC
Product code: Code HTW
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 ↗

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.