ORACLE SPACER, OPAL SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K072791
Device Name ORACLE SPACER, OPAL SPACER
Applicant
SYNTHES SPINE
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact stacey bonnell
Correspondent
SYNTHES SPINE
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact stacey bonnell
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 10/01/2007
Decision Date 12/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No