DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE


Device Classification Name

filler, bone void, osteoinduction (w/o human growth factor)

510(k) Number K080399
Device Name DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 may street
edison, 
NJ 
08837

Applicant Contact nancy b joy
Correspondent
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 may street
edison, 
NJ 
08837

Correspodent Contact nancy b joy
Regulation Number 888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received 02/14/2008
Decision Date 10/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No