Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K113170 |
Device Name |
CERVICAL PLATE |
Applicant |
EISERTECH, LLC |
2555 FRONT STREET |
SAN DIEGO,
CA
92103
|
|
Applicant Contact |
LUKAS EISERMANN |
Correspondent |
EISERTECH, LLC |
2555 FRONT STREET |
SAN DIEGO,
CA
92103
|
|
Correspondent Contact |
LUKAS EISERMANN |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 10/27/2011 |
Decision Date | 04/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|