PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT— 510(k) K970346

Substantially Equivalent

Kairos Orthopaedics

FDA 510(k) clearance K970346 for PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT, Substantially Equivalent on 1997-02-19. Applicant: Kairos Orthopaedics.

Clearance details

Applicant: Kairos Orthopaedics
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1997-01-30
Decision date: 1997-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, 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.