The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte Neuro System Bone Plate.
| Device ID | K103778 |
| 510k Number | K103778 |
| Device Name: | LEFORTE NEURO SYSTEM BONE PLATE |
| Classification | Plate, Bone |
| Applicant | JEIL MEDICAL CORPORATION 5966 EXETER CIRCLE Norcross, GA 30071 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner JEIL MEDICAL CORPORATION 5966 EXETER CIRCLE Norcross, GA 30071 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809265155751 | K103778 | 000 |
| 08806390805148 | K103778 | 000 |
| 08806390805131 | K103778 | 000 |
| 08806390805124 | K103778 | 000 |
| 08806390805100 | K103778 | 000 |
| 08806390805094 | K103778 | 000 |
| 08806390805087 | K103778 | 000 |
| 08806390805070 | K103778 | 000 |
| 08806390805063 | K103778 | 000 |
| 08806390805056 | K103778 | 000 |
| 08806390805155 | K103778 | 000 |
| 08806390805162 | K103778 | 000 |
| 08806390805179 | K103778 | 000 |
| 08809265155744 | K103778 | 000 |
| 08809265153689 | K103778 | 000 |
| 08809265153672 | K103778 | 000 |
| 08809265153665 | K103778 | 000 |
| 08809265150503 | K103778 | 000 |
| 08809265150497 | K103778 | 000 |
| 08806390805209 | K103778 | 000 |
| 08806390805193 | K103778 | 000 |
| 08806390805186 | K103778 | 000 |
| 08806390889049 | K103778 | 000 |