The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte System Bone Screw.
| Device ID | K023365 |
| 510k Number | K023365 |
| Device Name: | LEFORTE SYSTEM BONE SCREW |
| Classification | Screw, Fixation, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-04-18 |
| Summary: | summary |