The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Cervical.
| Device ID | K140066 |
| 510k Number | K140066 |
| Device Name: | INFILL CERVICAL |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814729025714 | K140066 | 000 |
| 00814729025585 | K140066 | 000 |
| 00814729025578 | K140066 | 000 |
| 00814729025561 | K140066 | 000 |
| 00814729025554 | K140066 | 000 |
| 00814729025547 | K140066 | 000 |
| 00814729025530 | K140066 | 000 |
| 00814729025523 | K140066 | 000 |
| 00814729025516 | K140066 | 000 |
| 00814729025509 | K140066 | 000 |
| 00814729025493 | K140066 | 000 |
| 00814729025592 | K140066 | 000 |
| 00814729025608 | K140066 | 000 |
| 00814729025707 | K140066 | 000 |
| 00814729025691 | K140066 | 000 |
| 00814729025684 | K140066 | 000 |
| 00814729025677 | K140066 | 000 |
| 00814729025660 | K140066 | 000 |
| 00814729025653 | K140066 | 000 |
| 00814729025646 | K140066 | 000 |
| 00814729025639 | K140066 | 000 |
| 00814729025622 | K140066 | 000 |
| 00814729025615 | K140066 | 000 |
| 00814729025486 | K140066 | 000 |