The following data is part of a premarket notification filed by Cmf Medicon Surgical Inc. with the FDA for Mediexpand Tl Expandable Vbr System.
| Device ID | K190349 |
| 510k Number | K190349 |
| Device Name: | MediExpand TL Expandable VBR System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | CMF Medicon Surgical Inc. 11200 St. Johns Industrial Pkwy N, Suite 1 Jacksonville, FL 32246 |
| Contact | Therese Davey |
| Correspondent | David Klementowski Regulatory Compliance Associates 102 Finwood Dr. Baldwinsville, NY 13027 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-10-24 |