MACROPORE OS TRAUMA


Device Classification Name

plate, fixation, bone

510(k) Number K021164
Device Name MACROPORE OS TRAUMA
Original Applicant
MACROPORE BIOSURGERY, INC.
6740 top gun st.
san diego, 
CA 
92121

Original Contact kenneth k kleinhenz
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 04/11/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized