Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K113625 |
Device Name |
DSS STABILIZATION SYSTEM |
Applicant |
PARADIGM SPINE, LLC |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
MICHELLE MCDONOUGH |
Correspondent |
PARADIGM SPINE, LLC |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
MICHELLE MCDONOUGH |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/08/2011 |
Decision Date | 01/10/2012 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|