HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON— 510(k) K111472

Substantially Equivalent

Tgm Medical

FDA 510(k) clearance K111472 for HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON, Substantially Equivalent on 2011-09-06. Applicant: Tgm Medical.

Clearance details

Applicant: Tgm Medical
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2011-05-27
Decision date: 2011-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado, CA, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.