MACROPORE OS RECONSTRUCTION


Device Classification Name

mesh, surgical, metal

510(k) Number K024169
Device Name MACROPORE OS RECONSTRUCTION
Original Applicant
MACROPORE BIOSURGERY, INC.
6740 top gun st.
san diego, 
CA 
92121

Original Contact kenneth k kleinhenz
Regulation Number 878.3300
Classification Product Code
EZX  
Subsequent Product Codes
HRS   HWC   MAI  
Date Received 12/18/2002
Decision Date 07/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No