Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K100845 |
Device Name |
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES |
Applicant |
ZIMMER SPINE, INC |
5301 RIATA PARK COURT |
BUILDING F |
AUSTIN,
TX
78727
|
|
Applicant Contact |
DAVID PADGETT, RAC (US) |
Correspondent |
ZIMMER SPINE, INC |
5301 RIATA PARK COURT |
BUILDING F |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
DAVID PADGETT, RAC (US) |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/25/2010 |
Decision Date | 09/21/2010 |
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
|
|
|