The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Jeil Bone Fixation System.
| Device ID | K050669 |
| 510k Number | K050669 |
| Device Name: | JEIL BONE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806390852135 | K050669 | 000 |
| 08806390805650 | K050669 | 000 |
| 08809265151050 | K050669 | 000 |
| 08809265155010 | K050669 | 000 |
| 08809265155065 | K050669 | 000 |
| 08809265155072 | K050669 | 000 |
| 08809265155133 | K050669 | 000 |
| 08809265150343 | K050669 | 000 |
| 08809265150350 | K050669 | 000 |
| 08806390805643 | K050669 | 000 |