NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT


Device Classification Name

filler, bone void, calcium compound

510(k) Number K080009
Device Name NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
Applicant
NovaBone Products, LLC
13709 progress blvd., #33
alachua, 
FL 
32615

Applicant Contact david m gaisser
Correspondent
NovaBone Products, LLC
13709 progress blvd., #33
alachua, 
FL 
32615

Correspodent Contact david m gaisser
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 01/03/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No