Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K110632 |
Device Name |
LUCENT OR LUCENT MAGNUM |
Applicant |
SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 |
CARLSBAD,
CA
90210
|
|
Applicant Contact |
BENJAMIN A KIMBALL |
Correspondent |
SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 |
CARLSBAD,
CA
90210
|
|
Correspondent Contact |
BENJAMIN A KIMBALL |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 03/04/2011 |
Decision Date | 05/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|