HEALOS II BONE GRAFT SUBSTITUTE


Device Classification Name

bone grafting material, synthetic

510(k) Number K081432
Device Name HEALOS II BONE GRAFT SUBSTITUTE
Applicant
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact hande tufan
Correspondent
DEPUY SPINE, INC.
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact hande tufan
Regulation Number 872.3930
Classification Product Code
LYC  
Subsequent Product Code
NPM  
Date Received 05/21/2008
Decision Date 08/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No