SPINESMITH CIMPLICITY SPINAL SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080971
Device Name SPINESMITH CIMPLICITY SPINAL SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
8140 n. mopac
bldg ii, suite 120
austin, 
TX 
78759

Applicant Contact robert jones
Correspondent
SPINE SMITH PARTNERS L.P.
8140 n. mopac
bldg ii, suite 120
austin, 
TX 
78759

Correspodent Contact robert jones
Regulation Number 888.3060
Classification Product Code
MQP  
Subsequent Product Code
ODP  
Date Received 04/04/2008
Decision Date 07/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No