PEEK SPINAL SPHERES


Device Classification Name

intervertebral fusion device with bone graft, solid-sphere, lumbar

510(k) Number K073105
Device Name PEEK SPINAL SPHERES
Applicant
INTERBODY INNOVATIONS, LLP
1001 oakwood blvd.
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
INTERBODY INNOVATIONS, LLP
1001 oakwood blvd.
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Classification Product Code
NVR  
Date Received 11/02/2007
Decision Date 01/03/2008
Decision

se – with limitations

(SESU)

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No