Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K122444 |
Device Name |
CERVICAL CAGE |
Applicant |
EISERTECH, LLC |
1133 COLUMBIA STREET |
SUITE 107 |
SAN DIEGO,
CA
92101
|
|
Applicant Contact |
LUKAS EISERMANN |
Correspondent |
EISERTECH, LLC |
1133 COLUMBIA STREET |
SUITE 107 |
SAN DIEGO,
CA
92101
|
|
Correspondent Contact |
LUKAS EISERMANN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/10/2012 |
Decision Date | 08/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|