ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED— 510(k) K033943

Name: FDA 510(k) clearance K033943
Creator: U.S. Food and Drug Administration
Published: 2004-10-18

Substantially Equivalent

Centerpulse Orthopedics, Inc.

FDA 510(k) clearance K033943 for ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED, Substantially Equivalent on 2004-10-18. Applicant: Centerpulse Orthopedics, Inc.. Device class: 3.

Clearance details

Applicant: Centerpulse Orthopedics, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2003-12-19
Decision date: 2004-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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 Centerpulse Orthopedics, Inc.

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K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED2004-09-15
K040947 — DURASUL BIPOLAR2004-08-27
K033810 — NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM2004-03-05
K033664 — MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM2003-12-17
K032348 — CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP2003-10-24

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.