Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K120714 |
Device Name |
PICASSO MIS SPINAL FIXATION SYSTEM |
Applicant |
ACCEL SPINE |
14850 Quorum Dr Ste 220 |
Dallas,
TX
75254
|
|
Applicant Contact |
DANIEL CHON |
Correspondent |
ACCEL SPINE |
14850 Quorum Dr Ste 220 |
Dallas,
TX
75254
|
|
Correspondent Contact |
DANIEL CHON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/08/2012 |
Decision Date | 08/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|