MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM— 510(k) K033664

Substantially Equivalent

Centerpulse Orthopedics, Inc.

FDA 510(k) clearance K033664 for MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM, Substantially Equivalent on 2003-12-17. Applicant: Centerpulse Orthopedics, Inc..

Clearance details

Applicant: Centerpulse Orthopedics, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2003-11-21
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.