Identity
- Trade Name
- LEVEL ONE CMF FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- PLATE, ORTHOG, LEFORT, LINDORF, LEFT, 1.5 MM SCREW, CP TITANIUM FDA UDI
- Model / Reference
- 50-280-02-09 FDA UDI
- Description
- PLATE, ORTHOG, LEFORT, LINDORF, LEFT, 1.5 MM SCREW, CP TITANIUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118073808 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Level One Cmf by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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- Leforte System Bone Plate — Jeil Medical Corporation · Class II
- AccuPlate® Patient-Specific Plate — Medcad · Class II
- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
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
- KLS-Martin L.P.
Sources (1)
- FDA UDI 9c21864c-d1aa-4495-a8e3-634e7e6e0db5 35 fields · synced May 31, 2026