Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K071857 |
Device Name |
DELTA SPINAL FUSION SYSTEM |
Applicant |
JEMO SPINE, LLC |
6170 SOUTH 380 WEST, SUITE 200 |
MURRAY,
UT
84107
|
|
Applicant Contact |
PATRICK MOORE |
Correspondent |
JEMO SPINE, LLC |
6170 SOUTH 380 WEST, SUITE 200 |
MURRAY,
UT
84107
|
|
Correspondent Contact |
PATRICK MOORE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/05/2007 |
Decision Date | 08/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|