The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Zenius Spinal System.
Device ID | K103272 |
510k Number | K103272 |
Device Name: | ZENIUS SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | MEDYSSEY CO., LTD. 6170 SOUTH 380 WEST SUITE 200 Murray, UT 84107 |
Contact | Patrick Moore |
Correspondent | Patrick Moore MEDYSSEY CO., LTD. 6170 SOUTH 380 WEST SUITE 200 Murray, UT 84107 |
Product Code | MNI |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-05 |
Decision Date | 2010-12-29 |
Summary: | summary |