SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR— 510(k) K870844

Substantially Equivalent

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K870844 for SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR, Substantially Equivalent on 1987-03-13. Applicant: Warsaw Orthopedic, Inc..

Clearance details

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

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Adverse events under product code HWB

product code HWB

Malfunction: 1,893
Total: 1,893

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.