ODALYS PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K111370
Device Name ODALYS PEDICLE SCREW SYSTEM
Applicant
KALITEC DIRECT, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
KALITEC DIRECT, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 05/16/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No