SYNTHES ACIS/VERTEBRAL SPACER CR— 510(k) K120275

Substantially Equivalent

Synthes (Usa), LLC

FDA 510(k) clearance K120275 for SYNTHES ACIS/VERTEBRAL SPACER CR, Substantially Equivalent on 2012-05-25. Applicant: Synthes (Usa), LLC.

Clearance details

Applicant: Synthes (Usa), LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-01-30
Decision date: 2012-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.