The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Medyssey Co., Ltd., Zenius Spinal System.
| Device ID | K093104 |
| 510k Number | K093104 |
| Device Name: | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDYSSEY CO., LTD. 6170 SOUTH 380 WEST SUITE 200 Murray, UT 84107 |
| Contact | Patrick D Moore |
| Correspondent | Patrick D Moore MEDYSSEY CO., LTD. 6170 SOUTH 380 WEST SUITE 200 Murray, UT 84107 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-06-25 |
| Summary: | summary |