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 | K112812 |
| 510k Number | K112812 |
| Device Name: | LEFORTE NEURO SYSTEM BONE PLATE |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| 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 | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268CRANCLOSIMP1 | K112812 | 000 |
| 08806390888851 | K112812 | 000 |