CIMPLICITY SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K073320
Device Name CIMPLICITY SPINAL SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
5300 north lamar blvd #107
austin, 
TX 
78751

Applicant Contact robert jones
Correspondent
SPINE SMITH PARTNERS L.P.
5300 north lamar blvd #107
austin, 
TX 
78751

Correspodent Contact robert jones
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 11/26/2007
Decision Date 02/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No