The following data is part of a premarket notification filed by Summit Spine with the FDA for Summit Spine Channel Cervical Interbody Fusion System.
| Device ID | K163494 |
| 510k Number | K163494 |
| Device Name: | Summit Spine Channel Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Summit Spine 2333 Airport Rd. Georgetown, TX 78628 |
| Contact | Eric Buescher |
| Correspondent | Eric Buescher Summit Spine 2333 Airport Rd. Georgetown, TX 78628 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-13 |
| Decision Date | 2017-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B528CO8141260 | K163494 | 000 |