DeviceClearance

PLUS BIPOLAR PROSTHESIS COCRMO— 510(k) K982447

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K982447 for PLUS BIPOLAR PROSTHESIS COCRMO, Substantially Equivalent on 1998-11-25. Applicant: Plus Orthopedics.

Clearance details

Applicant
Plus Orthopedics
Product code
Code KWY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWY

product code KWY
Death
3
Injury
2,049
Total
2,052

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.