SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K030087
Device Name SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
Original Applicant
SPINAL CONCEPTS, INC.
5301 riata park court
bldg f
austin, 
TX 
78727

Original Contact lisa peterson
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 01/09/2003
Decision Date 07/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No