DeviceClearance

Product code JDB— Orthopedic

ABC TOTAL ELBOW PROTHESIS

Classification name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device class
Class 2
Regulation
21 CFR 888.3160
Advisory panel
Orthopedic
Total cleared
27
First cleared
Most recent

Market context for product code JDB

FDA has cleared 27 devices under product code JDB between 1980 and 2022, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code JDB

Adverse events under product code JDB

product code JDB
Injury
352
Total
352

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 JDB

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