NGARDE SYSTEM


Device Classification Name

posterior metal/polymer spinal system, fusion

510(k) Number K072685
Device Name NGARDE SYSTEM
Applicant
N SPINE, INC.
6244 ferris square, suite b
san diego, 
CA 
92121 -3239

Applicant Contact jude v paganelli
Correspondent
N SPINE, INC.
6244 ferris square, suite b
san diego, 
CA 
92121 -3239

Correspodent Contact jude v paganelli
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 09/21/2007
Decision Date 10/19/2007
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls