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 |