Expander, Tissue, Orbital
The Expander, Tissue, Orbital (product code NFM) is an ophthalmic implant placed in the orbital cavity to gradually expand the tissue and stimulate orbital growth, commonly used in pediatric patients with anophthalmos or microphthalmos to develop the socket prior to prosthetic eye fitting. It is classified as an FDA Class 2 device within the Ophthalmic specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation and is not flagged as life-sustaining.
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Basic Information
- Product Code
- NFM
- Device Class
- FDA class 2
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.