Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K231199 |
Device Name |
Solar Lumbar Interbody Fusion 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 |
Justin Gracyalny |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/27/2023 |
Decision Date | 06/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|