CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K111115
Device Name CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
Applicant
CAPTIVA SPINE, INC
2361 nw 105th lane
sunrise, 
FL 
33322

Applicant Contact john sanders
Correspondent
CAPTIVA SPINE, INC
2361 nw 105th lane
sunrise, 
FL 
33322

Correspodent Contact john sanders
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 04/21/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No