The following data is part of a premarket notification filed by Degen Medical with the FDA for Latitude-c Cervical Interbody Spacer System.
Device ID | K151496 |
510k Number | K151496 |
Device Name: | Latitude-C Cervical Interbody Spacer System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | Degen Medical 1321-C North Cashua Drive Florence, SC 29501 |
Contact | Craig Black |
Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY SUITE 120 Woodstock, GA 30188 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-03 |
Decision Date | 2015-12-15 |
Summary: | summary |