NXM — Prosthesis, Eyelid Spacer/Graft, Biologic Class II
FDA product code NXM covers "Prosthesis, Eyelid Spacer/Graft, Biologic", a Class II medical device regulated under 21 CFR 886.3130. 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
- 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.