TIGRAN HIP PROSTHESIS— 510(k) K984492

Substantially Equivalent

Ponmed , Ltd.

FDA 510(k) clearance K984492 for TIGRAN HIP PROSTHESIS, Substantially Equivalent on 1999-03-15. Applicant: Ponmed , Ltd..

Clearance details

Applicant: Ponmed , Ltd.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1998-12-17
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.