The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Synapse System.
Device ID | K133698 |
510k Number | K133698 |
Device Name: | SYNAPSE SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
Contact | Laura Bleyendaal |
Correspondent | Laura Bleyendaal SYNTHES USA PRODUCTS LLC 325 Paramount Drive 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 | 2013-12-03 |
Decision Date | 2014-01-16 |
Summary: | summary |