Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K173524 |
Device Name |
ANAX 5.5™ Spinal System |
Applicant |
U&I Corporation |
20, Sandan-ro 76beon-gil(Rd) |
Uijeongbu-si,
KR
11781
|
|
Applicant Contact |
Jee Ae Bang |
Correspondent |
U&I Corporation |
20, Sandan-ro 76beon-gil(Rd) |
Uijeongbu-si,
KR
11781
|
|
Correspondent Contact |
Jee Ae Bang |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 11/14/2017 |
Decision Date | 12/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|