PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)— 510(k) K132626

Substantially Equivalent

Pipeline Biotechnology

FDA 510(k) clearance K132626 for PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION), Substantially Equivalent on 2013-09-19. Applicant: Pipeline Biotechnology.

Clearance details

Applicant
Pipeline Biotechnology
Product code
Code LPH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

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, through . 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.