The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Calix Lumbar Spinal Implant System.
| Device ID | K170119 |
| 510k Number | K170119 |
| Device Name: | Calix Lumbar Spinal Implant System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
| Contact | Charlene Brumbaugh |
| Correspondent | Charlene Brumbaugh X-Spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-13 |
| Decision Date | 2017-09-29 |
| Summary: | summary |