KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System— 510(k) K201660

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K201660 for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System, Substantially Equivalent on 2020-07-16. Applicant: Kyocera Medical Technologies, Inc..

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code OQG
Advisory panel: Orthopedic
Date received: 2020-06-18
Decision date: 2020-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.