The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Intervertebral Body Fusion Device.
| Device ID | K121733 |
| 510k Number | K121733 |
| Device Name: | INFILL INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-13 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814729024847 | K121733 | 000 |
| 00814729024656 | K121733 | 000 |
| 00814729024649 | K121733 | 000 |
| 00814729024632 | K121733 | 000 |
| 00814729024625 | K121733 | 000 |
| 00814729024618 | K121733 | 000 |
| 00814729024601 | K121733 | 000 |
| 00814729024595 | K121733 | 000 |
| 00814729024588 | K121733 | 000 |
| 00814729024571 | K121733 | 000 |
| 00814729024564 | K121733 | 000 |
| 00814729024557 | K121733 | 000 |
| 00814729024540 | K121733 | 000 |
| 00814729024533 | K121733 | 000 |
| 00814729024526 | K121733 | 000 |
| 00814729024519 | K121733 | 000 |
| 00814729024663 | K121733 | 000 |
| 00814729024670 | K121733 | 000 |
| 00814729024687 | K121733 | 000 |
| 00814729024830 | K121733 | 000 |
| 00814729024823 | K121733 | 000 |
| 00814729024816 | K121733 | 000 |
| 00814729024809 | K121733 | 000 |
| 00814729024793 | K121733 | 000 |
| 00814729024786 | K121733 | 000 |
| 00814729024779 | K121733 | 000 |
| 00814729024762 | K121733 | 000 |
| 00814729024755 | K121733 | 000 |
| 00814729024748 | K121733 | 000 |
| 00814729024731 | K121733 | 000 |
| 00814729024724 | K121733 | 000 |
| 00814729024717 | K121733 | 000 |
| 00814729024700 | K121733 | 000 |
| 00814729024694 | K121733 | 000 |
| 00814729024502 | K121733 | 000 |