DeviceClearance

K021549

Substantially Equivalent

CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM

Applicant
Std Mfg., Inc.
Product code
KXA
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stoughton, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KXA

product code KXA
Injury
324
Total
324

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.