SYGNAL DBM


Device Classification Name

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

510(k) Number K073329
Device Name SYGNAL DBM
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 may street
edison, 
NJ 
08837

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

Correspodent Contact nancy bennewitz
Regulation Number 888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received 11/27/2007
Decision Date 02/28/2008
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