SPINAL CONCEPTS INC. CADENCE AND TRAXIS

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

Correspodent Contact lisa peterson
Regulation Number 888.3060
Classification Product Code
MQP  
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