DeviceClearance

K983014

Substantially Equivalent

SUMMIT ACETABULAR SYSTEM

Applicant
Johnson & Johnson Professionals, Inc.
Product code
LPH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raynham, MA, US
Download summary PDF View 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.