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 |