Device Classification Name |
Orthosis, Spine, Plate, Laminoplasty, Metal
|
510(k) Number |
K032534 |
Device Name |
SYNTHES AFS |
Applicant |
SYNTHES SPINE |
1230 WILSON DRIVE |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JOHN WALSH |
Correspondent |
SYNTHES SPINE |
1230 WILSON DRIVE |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JOHN WALSH |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 08/15/2003 |
Decision Date | 04/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|