The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tyrx Neuro Absorbable Antibacterial Envelope (medium), Tyrx Neuro Absorbable Antibacterial Envelope (large).
| Device ID | K192636 |
| 510k Number | K192636 |
| Device Name: | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Medtronic, Inc. 8200 Coral Sea St NE Mounds View, MN 55112 |
| Contact | Nancy Cameron |
| Correspondent | Nancy Cameron Medtronic, Inc. 8200 Coral Sea St NE Mounds View, MN 55112 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-04-08 |