SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM— 510(k) K093299

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K093299 for SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, Substantially Equivalent on 2010-12-16. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code OAT
Advisory panel: Dental
Date received: 2009-10-21
Decision date: 2010-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.