The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Silex Sacroiliac Joint Fusion System.
| Device ID | K123702 |
| 510k Number | K123702 |
| Device Name: | SILEX SACROILIAC JOINT FUSION SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Contact | David Kirschman, M.d. |
| Correspondent | David Kirschman, M.d. X-SPINE SYSTEMS, INC. 452 ALEXANDERSVILLE RD. Miamisburg, OH 45342 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-03-11 |
| Summary: | summary |