GranOSTM - beta tricalcium phosphate synthetic bone granules— 510(k) K143692

Substantially Equivalent

Tcm Associates, Ltd.

FDA 510(k) clearance K143692 for GranOSTM - beta tricalcium phosphate synthetic bone granules, Substantially Equivalent on 2015-08-21. Applicant: Tcm Associates, Ltd..

Clearance details

Applicant: Tcm Associates, Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2014-12-24
Decision date: 2015-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naseing Essex, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.