The following data is part of a premarket notification filed by Changzhou Dean Medical Instrument Co, Ltd with the FDA for General Spinal System.
| Device ID | K134011 |
| 510k Number | K134011 |
| Device Name: | GENERAL SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-09-03 |
| Summary: | summary |