MNF — Implant, Temporal Class II

FDA Device Classification

FDA product code MNF covers "Implant, Temporal", a Class II medical device regulated under 21 CFR 878.3550. Submissions are reviewed by the General, Plastic Surgery 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
MNF
Device Class
Class II
Regulation Number
878.3550
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K111069osteosymbionicsOSTEOSYMBIONICS, ST TEMPORALIS IMPLANTSeptember 22, 2011
K002586porex surgical products groupMEDPOR PTERIONAL SURGICAL IMPLANTNovember 17, 2000