Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K223418 |
Device Name |
DeGen Impulse AM™ System |
Applicant |
DeGen Medical |
1321-C North Cashua Drive |
Florence,
SC
29501
|
|
Applicant Contact |
Craig Black |
Correspondent |
Secure BioMed Evaluations |
7828 Hickory Flat Highway Suite 120 |
Woodstock,
GA
30188
|
|
Correspondent Contact |
Linda Braddon |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/10/2022 |
Decision Date | 03/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|