Bicera Resorbable Bone Substitute— 510(k) K172237

Substantially Equivalent

Wiltrom Corporation Limited

FDA 510(k) clearance K172237 for Bicera Resorbable Bone Substitute, Substantially Equivalent on 2018-02-02. Applicant: Wiltrom Corporation Limited.

Clearance details

Applicant: Wiltrom Corporation Limited
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2017-07-25
Decision date: 2018-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei City, 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.