NFM — Expander, Tissue, Orbital Class II

FDA Device Classification

FDA product code NFM covers "Expander, Tissue, Orbital", a Class II medical device regulated under 21 CFR 886.3320. Submissions are reviewed by the Ophthalmic 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
NFM
Device Class
Class II
Regulation Number
886.3320
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060151innoviaORBITAL TISSUE EXPANDER (OTE)August 8, 2006
K010852iopOSMED TISSUE EXPANDERAugust 13, 2001