Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K190291 |
Device Name |
Addivation Medical Cervical Interbody System |
Applicant |
Addivation Medical, LLC |
44 Riverdale Avenue |
Monmouth Beach,
NJ
07750
|
|
Applicant Contact |
Gregory Stebbins |
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 | 02/11/2019 |
Decision Date | 07/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|