The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Calix-c Cervical Interbody Spacer.
| Device ID | K171075 |
| 510k Number | K171075 |
| Device Name: | Calix-C Cervical Interbody Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | X-Spine Systems, Inc. 452 Alexandersville Rd Miamisburg, OH 45342 |
| Contact | Kriss Andersson |
| Correspondent | Kriss Andersson X-Spine Systems, Inc. 452 Alexandersville Rd Miamisburg, OH 45342 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-11 |
| Decision Date | 2017-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M697X0030610PC1 | K171075 | 000 |