SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM— 510(k) K102656

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K102656 for SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM, Substantially Equivalent on 2010-12-20. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JEY
Advisory panel: Dental
Date received: 2010-09-15
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.