ORIA NATURA SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K073669
Device Name ORIA NATURA SPACER
Applicant
CHOICE SPINE, LP
8202 sherman road
chesterland, 
OH 
44026 -2141

Applicant Contact karen e warden
Correspondent
CHOICE SPINE, LP
8202 sherman road
chesterland, 
OH 
44026 -2141

Correspodent Contact karen e warden
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 12/26/2007
Decision Date 02/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No