Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly— 510(k) K173104

Substantially Equivalent

Total Joint Orthopedics, Inc.

FDA 510(k) clearance K173104 for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly, Substantially Equivalent on 2017-10-27. Applicant: Total Joint Orthopedics, Inc..

Clearance details

Applicant
Total Joint Orthopedics, Inc.
Product code
Code OQG
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OQG

product code OQG
Injury
249
Total
249

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.