CONSENSUS ZIRCONIA FEMORAL HEAD— 510(k) K955386

Substantially Equivalent for Some Indications

U.S. Medical Products, Inc.

FDA 510(k) clearance K955386 for CONSENSUS ZIRCONIA FEMORAL HEAD, Substantially Equivalent for Some Indications on 1996-02-20. Applicant: U.S. Medical Products, Inc..

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1995-11-22
Decision date: 1996-02-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
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.