Identity
- Trade Name
- NEOFACE FDA UDI
- Generic Name
- Orthopaedic fixation plate bending insert, single-use FDA UDI
- Device Name
- Insertion Screw 2.0mm FDA UDI
- Model / Reference
- 901.300 FDA UDI
- Description
- Insertion Screw 2.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899893216130 FDA UDI
- 510(k) Number
- K102641 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Orthopaedic fixation plate bending insert, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 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: Orthopaedic fixation plate bending insert, single-use
Neoface by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate bending insert, single-use.
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Cleared under the same submission
K102641 also covers:
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — Neoortho Produtos Ortopédicos S/A.
- NEOFACE — 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 da1a8a49-2c02-4a22-908b-a714de15147b 35 fields · synced May 30, 2026