Prosthesis, Eyelid Spacer/Graft, Biologic
The Prosthesis, Eyelid Spacer/Graft, Biologic (product code NXM) is a biologic implant used to reinforce and aid in the reconstruction of soft tissues of the eyelid following trauma, disease, or surgical excision. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 886.3130 within the Ophthalmic specialty. This device carries an implant flag, indicating it is placed within the body.
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Basic Information
- Product Code
- NXM
- Device Class
- FDA class 2
- Regulation Number
- 886.3130
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.