ISOLA POLYAXIAL WASHER— 510(k) K013441

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K013441 for ISOLA POLYAXIAL WASHER, Substantially Equivalent on 2001-11-16. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2001-10-17
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.