The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synapse System, Synthes Oc Fusion System.
Device ID | K141897 |
510k Number | K141897 |
Device Name: | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham, MA 02767 |
Contact | Mitch Ohiwa |
Correspondent | Mitch Ohiwa SYNTHES USA PRODUCTS, LLC 325 PARAMOUNT DRIVE Rayham, MA 02767 |
Product Code | KWP |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-14 |
Decision Date | 2014-09-25 |
Summary: | summary |