K230774

Substantially Equivalent

PERLA® TL System; TEKTONA® HV US Bone Cement

Applicant: Spineart
Product code: PML
Advisory panel: Orthopedic
Date received: 2023-03-21
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.