The following data is part of a premarket notification filed by Shanghai Sanyou Medical Co, Ltd with the FDA for Adena-zina System.
| Device ID | K152781 |
| 510k Number | K152781 |
| Device Name: | Adena-Zina System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SHANGHAI SANYOU MEDICAL CO, LTD 1988 JIATANG ROAD Jiadiang District, CN 201807 |
| Contact | David Fan |
| Correspondent | Kimberly Strohkirch MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-02-12 |
| Summary: | summary |