BIPOLAR HIP SYSTEM— 510(k) K892398

Name: FDA 510(k) clearance K892398
Creator: U.S. Food and Drug Administration
Published: 1989-05-23

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K892398 for BIPOLAR HIP SYSTEM, Substantially Equivalent on 1989-05-23. Applicant: Orthomet, Inc.. Device class: 2.

Clearance details

Applicant: Orthomet, Inc.
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 1989-04-07
Decision date: 1989-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT1994-12-28
K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM1994-11-30

Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.