H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED— 510(k) K901626

Name: FDA 510(k) clearance K901626
Creator: U.S. Food and Drug Administration
Published: 1990-08-14

Substantially Equivalent

Med-Tek Corp.

FDA 510(k) clearance K901626 for H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED, Substantially Equivalent on 1990-08-14. Applicant: Med-Tek Corp.. Device class: 3.

Clearance details

Applicant: Med-Tek Corp.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1990-04-09
Decision date: 1990-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

More clearances from Med-Tek Corp.

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K903234 — F-19 TOTAL HIP PROSTHESIS1990-10-10
K901687 — F-24 FEMORAL HIP PROSTHESIS1990-09-07
K901451 — F-20 CEMENTED METAL-BACKED ACETABULAR CUP1990-08-31
K900428 — ANESTHESIA BREATHING CIRCUITS1990-08-17
K901594 — H.N. TOTAL HIP PROSTHESIS1990-08-03

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.