4-WEB ALIF SPINAL TRUSS SYSTEM (STS)


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112316
Device Name 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
Applicant
4-WEB, INC.
13540 guild ave.
apple valley, 
MN 
55124

Applicant Contact rich jansen, pharm. d.
Correspondent
4-WEB, INC.
13540 guild ave.
apple valley, 
MN 
55124

Correspodent Contact rich jansen, pharm. d.
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 08/11/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls