Renovo Life Small Bone IM Nail System— 510(k) K161254

Substantially Equivalent

Renovo Life, LLC

FDA 510(k) clearance K161254 for Renovo Life Small Bone IM Nail System, Substantially Equivalent on 2016-11-07. Applicant: Renovo Life, LLC.

Clearance details

Applicant: Renovo Life, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2016-05-03
Decision date: 2016-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belmont, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.