MODIFICATION TO SYNTHES (USA) POLYPIN— 510(k) K003527

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K003527 for MODIFICATION TO SYNTHES (USA) POLYPIN, Substantially Equivalent on 2001-04-09. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2000-11-16
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.