MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K024313
Device Name MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
Original Applicant
PISHARODI SURGICALS, INC.
1001 oakwood blvd.
round rock, 
TX 
78681

Original Contact j.d. webb
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 12/24/2002
Decision Date 08/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No