Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K113149 |
Device Name |
SYNTHES USS CONNECTORS |
Applicant |
SYNTHES SPINE |
1302 WRIGHTS LN EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
HEATHER GUERIN |
Correspondent |
SYNTHES SPINE |
1302 WRIGHTS LN EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
HEATHER GUERIN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/24/2011 |
Decision Date | 02/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|