Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K152501 |
Device Name |
Spinal Jaxx Interbody Fusion Device |
Applicant |
NEUROPRO SPINAL JAXX, INC. |
4707 GREENLEAF CT., STE. C |
MODESTO,
CA
95356
|
|
Applicant Contact |
BENJAMIN J. REMINGTON |
Correspondent |
SILVER PINE CONSULTING, LLC. |
11821 BRAMBLE COVE DRIVE |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
RICH JANSEN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 09/01/2015 |
Decision Date | 06/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|