Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K182377 |
Device Name |
CarboClear® Pedicle Screw System |
Applicant |
CarboFix Orthopedics Ltd. |
11 Ha'hoshlim St. |
Herzeliya,
IL
4672411
|
|
Applicant Contact |
Hila Wachsler-Avrahami |
Correspondent |
CarboFix Orthopedics Ltd. |
11 Ha'hoshlim St. |
Herzeliya,
IL
4672411
|
|
Correspondent Contact |
Hila Wachsler-Avrahami |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 08/31/2018 |
Decision Date | 09/27/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|