The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for X-spine Pedicle Screw System.
| Device ID | K152132 |
| 510k Number | K152132 |
| Device Name: | X-spine Pedicle Screw System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
| Contact | David Kirschman |
| Correspondent | David Kirschman X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2015-09-25 |
| Summary: | summary |