VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K111983
Device Name VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY
10 pomeroy rd.
parsippany, 
NJ 
07054

Applicant Contact kathleen rutherford
Correspondent
ZIMMER TRABECULAR METAL TECHNOLOGY
10 pomeroy rd.
parsippany, 
NJ 
07054

Correspodent Contact kathleen rutherford
Regulation Number 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received 07/12/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No