MJW — Prosthesis, Subtalar, Plug, Polymer Class II

FDA Device Classification

FDA product code MJW covers "Prosthesis, Subtalar, Plug, Polymer", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MJW
Device Class
Class II
Regulation Number
888.3040
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K033046nexa orthopedicsSUBTALAR PEG IMPLANTDecember 23, 2003
K922292sgarlato laboratoriesLUNDEEN SUBTALAR PEG IMPLANTOctober 23, 1992