Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K050804 |
Device Name |
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
KATHY A RACOSKY |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
KATHY A RACOSKY |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 03/30/2005 |
Decision Date | 04/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|