SYNFIX-LR SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K072253
Device Name SYNFIX-LR SPACER
Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact susan lewandowski
Correspondent
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact susan lewandowski
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 08/14/2007
Decision Date 10/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls