CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K072537
Device Name CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
CREASPINE SAS
49 plain street
north attleboro, 
MA 
02760

Applicant Contact cynthia j.m nolte
Correspondent
CREASPINE SAS
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact cynthia j.m nolte
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 09/10/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No