FDA product code NXM: Prosthesis, Eyelid Spacer/Graft, Biologic
NXM is the FDA product code for prosthesis, eyelid spacer/graft, biologic. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under NXM. The average 510(k) review took 96 days (median 96).
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Eyelid Spacer/Graft, Biologic |
| Device class | Class II |
| Regulation | 21 CFR 886.3130 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every NXM clearance
Top NXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Iop, Inc. | 2 | 2009-05-08 |
Most recent NXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090078 | Iop, Inc. | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | 2009-05-08 | 116 |
| K053622 | Iop, Inc. | SURGISIS OCULAR GRAFT | 2006-03-15 | 77 |
Recalls for NXM devices
openFDA lists no recalls for product code NXM.
Frequently asked questions
What is FDA product code NXM?
NXM is the FDA product code for prosthesis, eyelid spacer/graft, biologic. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel.
What device class is NXM?
Class II, regulation 21 CFR 886.3130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXM?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most NXM clearances?
Iop, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NXM
- Run a recall and safety report across every NXM manufacturer
- Watch product code NXM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times