Identity
- Trade Name
- NEONAIL FDA UDI
- Generic Name
- Humerus nail, non-sterile FDA UDI
- Device Name
- Intramedullary Humeral Nail D9x220 mm FDA UDI
- Model / Reference
- 934.122 FDA UDI
- Description
- Intramedullary Humeral Nail D9x220 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899893201662 FDA UDI
- 510(k) Number
- K141103 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Humerus 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Humerus nail, non-sterile
Neonail by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humerus nail, non-sterile.
- AOS HUMERAL NAIL 8.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- HUMERAL NAIL — Biomet Orthopedics, Inc. · Class II
- HUMERAL NAIL — Biomet Orthopedics, Inc. · Class II
- HUMERAL NAIL — Biomet Orthopedics, Inc. · Class II
- AOS HUMERAL NAIL 9.0mm x 32.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- AOS HUMERAL NAIL 7.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- HUMERAL NAIL — Biomet Orthopedics, Inc. · Class II
- AOS HUMERAL NAIL 9.0mm x 27.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
Cleared under the same submission
K141103 also covers:
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
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
- Neoortho Produtos Ortopédicos S/A.
Sources (1)
- FDA UDI 534e7039-bae0-4204-8016-704a603c3d22 35 fields · synced May 31, 2026