The following data is part of a premarket notification filed by Degen Medical with the FDA for Impulse Interbody Fusion System.
Device ID | K201287 |
510k Number | K201287 |
Device Name: | Impulse Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-14 |
Decision Date | 2020-12-22 |
Summary: | summary |