BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD— 510(k) K953045

Substantially Equivalent for Some Indications

Biologically Oriented Prostheses

FDA 510(k) clearance K953045 for BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD, Substantially Equivalent for Some Indications on 1995-09-27. Applicant: Biologically Oriented Prostheses.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1995-06-30
Decision date: 1995-09-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Port Huron, MI, 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.