Leforte System Bone Plate 20L-CD-005
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809265153887 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112457 | Date18 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Leforte System Bone Plate
- Generic name
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Model / reference
- 20L-CD-005
- Primary DI / UDI-DI
- 08809265153887
- 510(k) Number
- FDA product code
- JEY
- GMDN term
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Device class
- Class II
- Regulation number
- 872.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Jeil Medical Corporation
Properties
Other properties (9)
- Supplied sterile: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No