BICERA (TM) RESORBABLE BONE SUBSTITUTE— 510(k) K110949

Substantially Equivalent

Wiltrom Corporation Limited

FDA 510(k) clearance K110949 for BICERA (TM) RESORBABLE BONE SUBSTITUTE, Substantially Equivalent on 2012-09-18. Applicant: Wiltrom Corporation Limited.

Clearance details

Applicant: Wiltrom Corporation Limited
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2011-04-04
Decision date: 2012-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chutung Township, Hsinchu, TW

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.