The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Certex Spinal Fixation System.
| Device ID | K160428 |
| 510k Number | K160428 |
| Device Name: | Certex Spinal Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
| Contact | David Kirschman |
| Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street Northwest, 12th Floor Washington, DC 20005 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-05-05 |
| Summary: | summary |