Identity
- Trade Name
- Leforte Neuro System Bone Screw FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- 14-NF-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809265155300 FDA UDI
- FDA Product Code
- HWC FDA UDIHBW FDA UDIGXR FDA UDIGWO FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI882.5360 FDA UDI882.5250 FDA UDI882.5320 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
Leforte Neuro System Bone Screw by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial bone screw, non-bioabsorbable.
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Cleared under the same submission
K091686 also covers:
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Leforte Neuro System Bone Screw — Jeil Medical Corporation
- Leforte Neuro System Bone Screw — Jeil Medical Corporation
- Leforte Neuro System Bone Screw — Jeil Medical Corporation
- Leforte Neuro System Bone Screw — Jeil Medical Corporation
- Leforte Neuro System Bone Screw — Jeil Medical Corporation
- Leforte System Bone Screw — Jeil Medical Corporation
- Leforte System Bone Screw — Jeil Medical Corporation
- Leforte System Bone Screw — Jeil Medical Corporation
K112812 also covers:
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
K141452 also covers:
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Neuro & Craniofacial Fixation System — Innovasis, Inc.
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
- Leforte Neuro System Bone Plate — Jeil Medical Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jeil Medical Corporation
Sources (1)
- FDA UDI 33b43f9e-ffd3-48a8-b671-56880fada8e9 33 fields · synced May 30, 2026