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NXM — Prosthesis, Eyelid Spacer/Graft, Biologic Class II

FDA Device Classification

Classification Details

Product Code
NXM
Device Class
Class II
Regulation Number
886.3130
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Definition

For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K090078iopKERASYS BIOENGINEERED LAMELLAR PATCH GRAFTMay 8, 2009
K053622iopSURGISIS OCULAR GRAFTMarch 15, 2006