4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K121741
Device Name 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
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
ODP  
Date Received 06/13/2012
Decision Date 10/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No