SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS— 510(k) K111667

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K111667 for SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS, Substantially Equivalent on 2011-12-05. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 2011-06-14
Decision date: 2011-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.