Identity
- Trade Name
- 13MM FUSION NAIL, RIGHT FDA UDI
- Generic Name
- Arthrodesis nail, non-sterile FDA UDI
- Model / Reference
- 21590 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209215900 FDA UDI
- 510(k) Number
- K163627 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis nail, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Arthrodesis nail, non-sterile
13mm Fusion Nail, Right by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis nail, non-sterile.
- Vilex Fibula Nail — Vilex, Inc. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
- ENDER NAIL — Smith & Nephew, Inc. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
- NEONAIL — Neoortho Produtos Ortopédicos S/A. · Class II
Cleared under the same submission
K163627 also covers:
- 10MM NAIL CAP — BIOPRO, INC.
- 10MM NAIL CAP — BIOPRO, INC.
- 10MM NAIL CAP + 5MM — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 12MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 12MM NAIL CAP + 5MM — BIOPRO, INC.
- 13MM NAIL CAP — BIOPRO, INC.
- 14MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 15MM FUSION NAIL, LEFT — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI c522164c-bb01-4e5b-a8bc-9d337c6459a0 33 fields · synced Jun 8, 2026