Identity
- Trade Name
- NEOFACE FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- Self Drilling Screw Ø 2.0x 17 mm FDA UDI
- Model / Reference
- 924.032 FDA UDI
- Description
- Self Drilling Screw Ø 2.0x 17 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898624866477 FDA UDI
- 510(k) Number
- K102641 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable 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
Yes
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: Craniofacial bone screw, non-bioabsorbable
Neoface by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- OsteoMed — Osteomed Corp. · Class II
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- MatrixMANDIBLE — Synthes · Class II
- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II
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 d076be31-0a15-4ff8-8ac1-cee823c95c65 35 fields · synced Jun 6, 2026