Identity
- Trade Name
- Leforte System Bone Screw FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- 241.021411 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806390803311 FDA UDI
- 510(k) Number
- K150965 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable 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 bone screw, non-bioabsorbable
Leforte 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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- MatrixMANDIBLE — Synthes · Class II
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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 52df0f6d-1083-4c42-abc3-399b76f06c9c 33 fields · synced Jun 8, 2026