SCHULTZ PHALANGEAL COMPONENT DRIVER— 510(k) K870847

Substantially Equivalent

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K870847 for SCHULTZ PHALANGEAL COMPONENT DRIVER, Substantially Equivalent on 1987-03-13. Applicant: Warsaw Orthopedic, Inc..

Clearance details

Applicant: Warsaw Orthopedic, Inc.
Product code: Code HWR
Advisory panel: Orthopedic
Date received: 1987-03-03
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWR

product code HWR

Malfunction: 6,549
Total: 6,549

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.