DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS— 510(k) K053292

Substantially Equivalent

Scient'X USA, Inc.

FDA 510(k) clearance K053292 for DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS, Substantially Equivalent on 2006-01-19. Applicant: Scient'X USA, Inc..

Clearance details

Applicant: Scient'X USA, Inc.
Product code: 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

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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.