INTER-OP METASUL ACETABULAR SYSTEM— 510(k) K974728

Substantially Equivalent

Sulzer Orthopedics, Inc.

FDA 510(k) clearance K974728 for INTER-OP METASUL ACETABULAR SYSTEM, Substantially Equivalent on 1999-08-03. Applicant: Sulzer Orthopedics, Inc..

Clearance details

Applicant: Sulzer Orthopedics, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1997-12-18
Decision date: 1999-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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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.