DeviceClearance

Product code JDL— Orthopedic

101-32 FEMORAL COMPONENT

Classification name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class
Class 3
Regulation
21 CFR 888.3320
Advisory panel
Orthopedic
Total cleared
45
First cleared
Most recent

Market context for product code JDL

FDA has cleared 45 devices under product code JDL between 1977 and 2008, filed by 25 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

last 15 years

Top applicants under product code JDL

Adverse events under product code JDL

product code JDL
Injury
285
Total
285

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 →

Recent clearances under product code JDL

Data sourced from openFDA. This site is unofficial and independent of the FDA.