VARILIFT CERVICAL INTERBODY FUSION SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111123
Device Name VARILIFT CERVICAL INTERBODY FUSION SYSTEM
Applicant
WENZEL SPINE
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact sourabh mishra
Correspondent
WENZEL SPINE
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact sourabh mishra
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 04/21/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No