Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K123552 |
Device Name |
INSTINCT JAVA SYSTEM |
Applicant |
ZIMMER SPINE |
7375 BUSH LAKE ROAD |
EDINA,
MN
55439
|
|
Applicant Contact |
ELSA A LINKE |
Correspondent |
ZIMMER SPINE |
7375 BUSH LAKE ROAD |
EDINA,
MN
55439
|
|
Correspondent Contact |
ELSA A LINKE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/19/2012 |
Decision Date | 04/19/2013 |
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
|
|
|