The following data is part of a premarket notification filed by Johnson And Johnson with the FDA for Expedium Spine System/synapse System.
| Device ID | K142460 |
| 510k Number | K142460 |
| Device Name: | EXPEDIUM Spine System/Synapse System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | JOHNSON AND JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Jaclyn Porsolt |
| Correspondent | Jaclyn Porsolt JOHNSON AND JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2014-10-01 |
| Summary: | summary |