Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K050553 |
Device Name |
NOVEL VBR SPINAL SYSTEM |
Applicant |
ALPHATEC/NEXMED |
6110 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
ELLEN A YARNALL |
Correspondent |
ALPHATEC/NEXMED |
6110 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
ELLEN A YARNALL |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 03/03/2005 |
Decision Date | 04/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|