NUVASIVE HELIX ACP SYSTEM

Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K071329
Device Name NUVASIVE HELIX ACP SYSTEM
Applicant
NUVASIVE, INC.
4545 towne centre court
san diego, 
CA 
92121

Applicant Contact laetitia cousin
Correspondent
NUVASIVE, INC.
4545 towne centre court
san diego, 
CA 
92121

Correspodent Contact laetitia cousin
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 05/11/2007
Decision Date 08/08/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No