SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K072672
Device Name SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
Applicant
ABBOTT SPINE, INC.
5301 riata park ct., bldg. f
austin, 
TX 
78727

Applicant Contact david padgett
Correspondent
ABBOTT SPINE, INC.
5301 riata park ct., bldg. f
austin, 
TX 
78727

Correspodent Contact david padgett
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 09/21/2007
Decision Date 11/28/2007
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