The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Porousfit Implant.
| Device ID | K211514 |
| 510k Number | K211514 |
| Device Name: | Longeviti PorousFit Implant |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley, MD 21030 |
| Contact | Heather Hourihan |
| Correspondent | Heather Hourihan Longeviti Neuro Solutions, LLC 303 International Circle Suite 190 Hunt Valley, MD 21030 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855113008449 | K211514 | 000 |
| 00855113008647 | K211514 | 000 |
| 00855113008654 | K211514 | 000 |
| 00855113008678 | K211514 | 000 |
| 00855113008302 | K211514 | 000 |
| 00855113008319 | K211514 | 000 |
| 00855113008326 | K211514 | 000 |
| 00855113008333 | K211514 | 000 |
| 00855113008340 | K211514 | 000 |
| 00855113008357 | K211514 | 000 |
| 00855113008364 | K211514 | 000 |
| 00855113008371 | K211514 | 000 |
| 00855113008388 | K211514 | 000 |
| 00855113008395 | K211514 | 000 |
| 00855113008401 | K211514 | 000 |
| 00855113008418 | K211514 | 000 |
| 00855113008425 | K211514 | 000 |
| 00855113008432 | K211514 | 000 |
| 00855113008630 | K211514 | 000 |