Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K122622 |
Device Name |
ENDURAMESH |
Applicant |
LUCERO MEDICAL, LLC |
33490 PIN OAK PARKWAY |
AVON LAKE,
OH
44012
|
|
Applicant Contact |
JENNIFER PALINCHIK |
Correspondent |
LUCERO MEDICAL, LLC |
33490 PIN OAK PARKWAY |
AVON LAKE,
OH
44012
|
|
Correspondent Contact |
JENNIFER PALINCHIK |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 08/28/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|