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 |