The following data is part of a premarket notification filed by Shanghai Sanyou Medical Co, Ltd with the FDA for Katia System.
| Device ID | K131512 |
| 510k Number | K131512 |
| Device Name: | KATIA SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SHANGHAI SANYOU MEDICAL CO, LTD 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Contact | Kimberly Strohkirch |
| Correspondent | Kimberly Strohkirch SHANGHAI SANYOU MEDICAL CO, LTD 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-08-07 |
| Summary: | summary |