Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K211501 |
Device Name |
Advantage-C PEEK Cervical lnterbody Fusion Device |
Applicant |
lntelivation, LLC |
70 Gruber Lane |
Saint Simons Island,
GA
31522
|
|
Applicant Contact |
Jack Griffis |
Correspondent |
lntelivation, LLC |
70 Gruber Lane |
Saint Simons Island,
GA
31522
|
|
Correspondent Contact |
Jack Griffis |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/14/2021 |
Decision Date | 08/24/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|