OPTIMA, SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K024096
Device Name OPTIMA, SPINAL SYSTEM
Original Applicant
U&I CORP., AMERICA
6132 south 380 west,
murray, 
UT 
84107 -6988

Original Contact patrick moore
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWQ   MNH  
Date Received 12/12/2002
Decision Date 03/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls