CAPTIVA SPINE FUSELOX CERVICAL CAGE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K110585
Device Name CAPTIVA SPINE FUSELOX CERVICAL CAGE
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 888.3080
Classification Product Code
ODP  
Date Received 03/01/2011
Decision Date 03/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No