K102180

Substantially Equivalent

RHEAD RADIAL HEAD EXTENDED STEMS

Applicant: Small Bone Innovations, Inc.
Product code: JDB
Advisory panel: Orthopedic
Date received: 2010-08-02
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, PA, US

Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.