BIOFOAM BONE WEDGE


Device Classification Name

plate, fixation, bone

510(k) Number K073535
Device Name BIOFOAM BONE WEDGE
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact brad sheals
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact brad sheals
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 12/17/2007
Decision Date 01/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No