510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NXMClass II

Prosthesis, Eyelid Spacer/Graft, Biologic

21 CFR 886.3130 / Ophthalmic
FDA source (opens on fda.gov)

NXM is the FDA product code for Prosthesis, Eyelid Spacer/Graft, Biologic, a class II device type, regulated under 21 CFR 886.3130. FDA's definition for this code reads: "For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NXM
Device name
Prosthesis, Eyelid Spacer/Graft, Biologic
FDA definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NXM

By decision year
2 clearances under product code NXM with a decision year between 2006 and 2009, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NXM by decision year
YearClearances
20061
20091

Applicants with the most clearances

Product code NXM
Applicants holding the most 510(k) clearances under product code NXM
ApplicantClearances
Iop, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code