V.E.P. HIP -VARIABLE ENDO-PROSTHESIS— 510(k) K850928

Substantially Equivalent

Unitas Ent.

FDA 510(k) clearance K850928 for V.E.P. HIP -VARIABLE ENDO-PROSTHESIS, Substantially Equivalent on 1985-05-28. Applicant: Unitas Ent..

Clearance details

Applicant: Unitas Ent.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1985-03-05
Decision date: 1985-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.