Catalyst Bone Void Filler— 510(k) K232315

Substantially Equivalent

Ossdsign AB

FDA 510(k) clearance K232315 for Catalyst Bone Void Filler, Substantially Equivalent on 2023-09-15. Applicant: Ossdsign AB.

Clearance details

Applicant: Ossdsign AB
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2023-08-02
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, IE

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.