ICON (TM) MODULAR PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111448
Device Name ICON (TM) MODULAR PEDICLE SCREW SYSTEM
Applicant
ORTHOFIX, INC.
3451 plano parkway
lewisville, 
TX 
75056

Applicant Contact darla chew
Correspondent
ORTHOFIX, INC.
3451 plano parkway
lewisville, 
TX 
75056

Correspodent Contact darla chew
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 05/24/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No