MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT— 510(k) K063033

Substantially Equivalent

Orthopedic Sciences, Inc.

FDA 510(k) clearance K063033 for MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT, Substantially Equivalent on 2006-11-01. Applicant: Orthopedic Sciences, Inc..

Clearance details

Applicant: Orthopedic Sciences, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2006-10-03
Decision date: 2006-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Seal Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.