The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Novel Spinal System.
Device ID | K081153 |
510k Number | K081153 |
Device Name: | NOVEL SPINAL SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | MEDYSSEY CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
Contact | Jung Bae Bang |
Correspondent | Jung Bae Bang MEDYSSEY CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-23 |
Decision Date | 2009-01-30 |
Summary: | summary |