NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL— 510(k) K111572

Substantially Equivalent

Serf

FDA 510(k) clearance K111572 for NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL, Substantially Equivalent on 2011-08-29. Applicant: Serf.

Clearance details

Applicant: Serf
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2011-06-06
Decision date: 2011-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, 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.