CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080860
Device Name CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
CREASPINE
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact cynthia j nolte
Correspondent
CREASPINE
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact cynthia j nolte
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 03/27/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No