Product code MJW— Orthopedic

LUNDEEN SUBTALAR PEG IMPLANT

Classification name
Prosthesis, Subtalar, Plug, Polymer
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

Market context for product code MJW

FDA has cleared 2 devices under product code MJW between 1992 and 2003, filed by 2 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

Top applicants under product code MJW

Recent clearances under product code MJW

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