CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM— 510(k) K935193

Substantially Equivalent for Some Indications

U.S. Medical Products, Inc.

FDA 510(k) clearance K935193 for CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM, Substantially Equivalent for Some Indications on 1994-08-18. Applicant: U.S. Medical Products, Inc..

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1993-10-26
Decision date: 1994-08-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.