The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Oblique Tlif Device.
| Device ID | K124012 |
| 510k Number | K124012 |
| Device Name: | INFILL OBLIQUE TLIF 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-27 |
| Decision Date | 2013-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814729025295 | K124012 | 000 |
| 00814729025141 | K124012 | 000 |
| 00814729025134 | K124012 | 000 |
| 00814729025127 | K124012 | 000 |
| 00814729025110 | K124012 | 000 |
| 00814729025103 | K124012 | 000 |
| 00814729025097 | K124012 | 000 |
| 00814729025080 | K124012 | 000 |
| 00814729025073 | K124012 | 000 |
| 00814729025066 | K124012 | 000 |
| 00814729025059 | K124012 | 000 |
| 00814729025042 | K124012 | 000 |
| 00814729025158 | K124012 | 000 |
| 00814729025165 | K124012 | 000 |
| 00814729025172 | K124012 | 000 |
| 00814729025288 | K124012 | 000 |
| 00814729025271 | K124012 | 000 |
| 00814729025264 | K124012 | 000 |
| 00814729025257 | K124012 | 000 |
| 00814729025240 | K124012 | 000 |
| 00814729025233 | K124012 | 000 |
| 00814729025226 | K124012 | 000 |
| 00814729025219 | K124012 | 000 |
| 00814729025202 | K124012 | 000 |
| 00814729025196 | K124012 | 000 |
| 00814729025189 | K124012 | 000 |
| 00814729025035 | K124012 | 000 |