Prosthesis, Nail
The Nail Prosthesis is a general surgery device designed to replace a natural fingernail or toenail, typically used for cosmetic or protective purposes following nail loss due to injury, disease, or surgical removal. This device is currently unclassified by the FDA, reviewed by the General and Plastic Surgery panel, with its formal regulatory classification yet to be established. The product code is MQZ.
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Basic Information
- Product Code
- MQZ
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230841 | NailLift | Jan 22, 2024 | Substantially Equivalent | Jps Corporation |
| K162525 | Oniko nail brace | Apr 25, 2018 | Substantially Equivalent | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti |
| K960843 | STOP-N-GROW | Aug 12, 1996 | Substantially Equivalent | European Touch Co., Inc. |
| K850803 | NAIL SPLINT | Oct 16, 1985 | Substantially Equivalent | Inro Medical Designs, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.