The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte Neuro System Bone Plate And Screw.
| Device ID | K141452 |
| 510k Number | K141452 |
| Device Name: | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | JEIL MEDICAL CORPORATION 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung JEIL MEDICAL CORPORATION 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| 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 | 2014-06-02 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711CRT16040 | K141452 | 000 |
| M711CRT030BR0 | K141452 | 000 |
| M711CRT020GP0 | K141452 | 000 |
| M711CRT006ST0 | K141452 | 000 |
| M711CRT006DY0 | K141452 | 000 |
| M711CRT004ST0 | K141452 | 000 |
| M711CRT004SQ0 | K141452 | 000 |
| M711CRT002ST0 | K141452 | 000 |
| 08809282812392 | K141452 | 000 |
| 08809282812385 | K141452 | 000 |
| 08809282812378 | K141452 | 000 |
| M711CRT031BR0 | K141452 | 000 |
| M711CRT032BR0 | K141452 | 000 |
| M711CRT040BR0 | K141452 | 000 |
| M711CRT14050 | K141452 | 000 |
| M711CRT14040 | K141452 | 000 |
| M711CRT14030 | K141452 | 000 |
| M711CRT106DY0 | K141452 | 000 |
| M711CRT104ST0 | K141452 | 000 |
| M711CRT104SQ0 | K141452 | 000 |
| M711CRT102ST0 | K141452 | 000 |
| M711CRT100UT030 | K141452 | 000 |
| M711CRT042BR0 | K141452 | 000 |
| M711CRT041BR0 | K141452 | 000 |
| 08809282812361 | K141452 | 000 |