Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K071890 |
Device Name |
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM |
Applicant |
ALPHATEC SPINE, INC. |
2051 PALOMAR AIRPORT ROAD |
SUITE 100 |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
MARY STANNERS |
Correspondent |
ALPHATEC SPINE, INC. |
2051 PALOMAR AIRPORT ROAD |
SUITE 100 |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
MARY STANNERS |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2007 |
Decision Date | 11/09/2007 |
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
|
|
|