NUVASIVE SURGICAL MESH SYSTEM


Device Classification Name

mesh, surgical, polymeric

510(k) Number K081377
Device Name NUVASIVE SURGICAL MESH SYSTEM
Applicant
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Applicant Contact laetitia cousin
Correspondent
NUVASIVE, INC.
7475 lusk blvd
san diego, 
CA 
92121

Correspodent Contact laetitia cousin
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 05/16/2008
Decision Date 01/15/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No