The following data is part of a premarket notification filed by Changzhou Orthmed Medical Instrument Co., Ltd. with the FDA for Devine Spinal System.
| Device ID | K111690 |
| 510k Number | K111690 |
| Device Name: | DEVINE SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-16 |
| Decision Date | 2011-11-22 |
| Summary: | summary |