The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Capless Li Pedicle Screw System.
| Device ID | K072282 |
| 510k Number | K072282 |
| Device Name: | CAPLESS LI PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2007-09-14 |