Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K031823 |
Device Name |
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 |
Applicant |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
MARCI HALEVI |
Correspondent |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
MARCI HALEVI |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/13/2003 |
Decision Date | 07/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|