Identity
- Trade Name
- Leforte System Bone Plate FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- 242.30CH04.B4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806390801997 FDA UDI
- 510(k) Number
- K150965 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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 fixation plate, non-bioabsorbable, non-customized
Leforte System Bone Plate by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- CMF VISIONARE — VISIONARE LLC · Class II
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- AccuPlate® Patient-Specific Plate — Medcad · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- LEVEL ONE CMF, STERILE — KLS-Martin L.P. · Class II
- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
Cleared under the same submission
K150965 also covers:
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte System Bone Plate — Jeil Medical Corporation
- Leforte 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 |
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Manufacturer
- Manufacturer
- Jeil Medical Corporation
Sources (1)
- FDA UDI 37455e7c-511d-4cdc-93f3-d05844707fdc 33 fields · synced May 30, 2026