PRODENSE Bone Graft Substitute— 510(k) K181255

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K181255 for PRODENSE Bone Graft Substitute, Substantially Equivalent on 2018-09-12. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2018-05-11
Decision date: 2018-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.