Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K042714 |
Device Name |
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 |
Applicant |
SPINE NEXT AMERICA CORPORATION |
8381 DIX ELLIS TRAIL, STE. 110 |
JACKSONVILLE,
FL
32256
|
|
Applicant Contact |
TOM BREWER |
Correspondent |
SPINE NEXT AMERICA CORPORATION |
8381 DIX ELLIS TRAIL, STE. 110 |
JACKSONVILLE,
FL
32256
|
|
Correspondent Contact |
TOM BREWER |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 09/24/2004 |
Decision Date | 12/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|