The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Clearfit™ Ots Cranial Implants.
| Device ID | K212058 |
| 510k Number | K212058 |
| Device Name: | Longeviti ClearFit™ OTS Cranial Implants |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| 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 | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-01 |
| Decision Date | 2021-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855113008555 | K212058 | 000 |
| 00855113008128 | K212058 | 000 |
| 00855113008135 | K212058 | 000 |
| 00855113008142 | K212058 | 000 |
| 00855113008159 | K212058 | 000 |
| 00855113008272 | K212058 | 000 |
| 00855113008289 | K212058 | 000 |
| 00855113008296 | K212058 | 000 |
| 00855113008494 | K212058 | 000 |
| 00855113008500 | K212058 | 000 |
| 00855113008548 | K212058 | 000 |
| 00855113008111 | K212058 | 000 |