The following data is part of a premarket notification filed by Spinenet, Llc with the FDA for Daytona Anterior Cervical Cage.
| Device ID | K110733 |
| 510k Number | K110733 |
| Device Name: | DAYTONA ANTERIOR CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINENET, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SPINENET, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B047CTRC1400 | K110733 | 000 |
| B047CL1214080 | K110733 | 000 |
| B047CL1214070 | K110733 | 000 |
| B047CL1214060 | K110733 | 000 |
| B047CL1214050 | K110733 | 000 |
| B047CL1012100 | K110733 | 000 |
| B047CL1012090 | K110733 | 000 |
| B047CL1012080 | K110733 | 000 |
| B047CL1012070 | K110733 | 000 |
| B047CL1012060 | K110733 | 000 |
| B047CL1012050 | K110733 | 000 |
| B047CINS1100 | K110733 | 000 |
| B047CGRP1300 | K110733 | 000 |
| B047CL1214090 | K110733 | 000 |
| B047CL1214100 | K110733 | 000 |
| B047CTL1214100 | K110733 | 000 |
| B047CTL1214090 | K110733 | 000 |
| B047CTL1214080 | K110733 | 000 |
| B047CTL1214070 | K110733 | 000 |
| B047CTL1214060 | K110733 | 000 |
| B047CTL1214050 | K110733 | 000 |
| B047CTL1012100 | K110733 | 000 |
| B047CTL1012090 | K110733 | 000 |
| B047CTL1012080 | K110733 | 000 |
| B047CTL1012070 | K110733 | 000 |
| B047CTL1012060 | K110733 | 000 |
| B047CTL1012050 | K110733 | 000 |
| B047CGRB1200 | K110733 | 000 |