Device Classification Name |
Appliance, Fixation, Spinal Interlaminal
|
510(k) Number |
K093438 |
Device Name |
PARADIGM INTERSPINOUS FUSION PLATE |
Applicant |
PARADIGM SPINE, LLC |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
JUSTIN EGGLETON |
Correspondent |
PARADIGM SPINE, LLC |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
JUSTIN EGGLETON |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 11/04/2009 |
Decision Date | 10/06/2010 |
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
|
|
|