BETA-TCP GRANULES— 510(k) K120354

Substantially Equivalent

Skeletal Kinetics, LLC

FDA 510(k) clearance K120354 for BETA-TCP GRANULES, Substantially Equivalent on 2013-03-21. Applicant: Skeletal Kinetics, LLC.

Clearance details

Applicant: Skeletal Kinetics, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2012-02-06
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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.