The following data is part of a premarket notification filed by Longeviti Neuro Solutions, Llc with the FDA for Longeviti Pmma Static Cranial Implant.
| Device ID | K170410 |
| 510k Number | K170410 |
| Device Name: | Longeviti PMMA Static Cranial Implant |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Longeviti Neuro Solutions, LLC 303 International Circle Suite T128 Hunt Valley, MD 21030 |
| Contact | Kevin Lee |
| Correspondent | Elaine Duncan Longeviti Neuro Solutions, LLC P.O. Box 560 Stillwater, MN 55082 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855113008043 | K170410 | 000 |
| 00855113008036 | K170410 | 000 |
| 00855113008029 | K170410 | 000 |
| 00855113008012 | K170410 | 000 |
| 00855113008005 | K170410 | 000 |
| 90855113008084 | K170410 | 000 |
| 00855113008098 | K170410 | 000 |