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

Name: FDA 510(k) clearance K850928
Creator: U.S. Food and Drug Administration
Published: 1985-05-28

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.. Device class: 2.

Clearance details

Applicant: Unitas Ent.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1985-03-05
Decision date: 1985-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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.