K053292

Substantially Equivalent

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

Applicant: Scient'X USA, Inc.
Product code: MQP
Advisory panel: Orthopedic
Date received: 2005-11-25
Decision date: 2006-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.