OTI MODULAR SHOULDER SYSTEM— 510(k) K982886

Substantially Equivalent

Osteoimplant Technology, Inc.

FDA 510(k) clearance K982886 for OTI MODULAR SHOULDER SYSTEM, Substantially Equivalent on 1998-10-05. Applicant: Osteoimplant Technology, Inc..

Clearance details

Applicant: Osteoimplant Technology, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1998-08-17
Decision date: 1998-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.