NOVABONE MACROPOR-SI+ – BIOACTIVE BONE GRAFT


Device Classification Name

filler, bone void, calcium compound

510(k) Number K110925
Device Name NOVABONE MACROPOR-SI+ – BIOACTIVE BONE GRAFT
Applicant
NovaBone Products, LLC
13631 progress blvd
suite 600
alachua, 
FL 
32615

Applicant Contact david m gaisser
Correspondent
NovaBone Products, LLC
13631 progress blvd
suite 600
alachua, 
FL 
32615

Correspodent Contact david m gaisser
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 04/01/2011
Decision Date 07/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No