NXM · Class II · 21 CFR 886.3130

FDA Product Code NXM: Prosthesis, Eyelid Spacer/graft, Biologic

For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid.

Leading manufacturers include Iop, Inc..

2
Total
2
Cleared
97d
Avg days
2006
Since

FDA 510(k) Cleared Prosthesis, Eyelid Spacer/graft, Biologic Devices (Product Code NXM)

2 devices
1–2 of 2
Cleared May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K090078
Iop, Inc.
Ophthalmic · 116d
Cleared Mar 15, 2006
SURGISIS OCULAR GRAFT
K053622
Iop, Inc.
Ophthalmic · 77d

About Product Code NXM - Regulatory Context