COPSIOS BONE VOID FILLER (BVF)

Device Classification Name

filler, bone void, calcium compound

510(k) Number K033679
Device Name COPSIOS BONE VOID FILLER (BVF)
Applicant
CENTERPULSE SPINE-TECH, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439 -2027

Applicant Contact tim miller
Correspondent
CENTERPULSE SPINE-TECH, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439 -2027

Correspodent Contact tim miller
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 11/24/2003
Decision Date 07/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No