The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Fixcet Spinal Facet Screw System.
| Device ID | K100154 |
| 510k Number | K100154 |
| Device Name: | FIXCET SPINAL FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| 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 | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-20 |
| Decision Date | 2010-05-21 |
| Summary: | summary |