Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K033517 |
Device Name |
SPINAL CONCEPTS INC. CADENCE AND TRAXIS |
Applicant |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Applicant Contact |
LISA PETERSON |
Correspondent |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
LISA PETERSON |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 11/07/2003 |
Decision Date | 02/18/2004 |
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
|
|
|