ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM


Device Classification Name

filler, bone void, calcium compound

510(k) Number K110976
Device Name ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
Applicant
NANOTHERAPEUTICS, INC.
13859 progress blvd,
suite 300
alachua, 
FL 
32615

Applicant Contact dennis tomisaka
Correspondent
NANOTHERAPEUTICS, INC.
13859 progress blvd,
suite 300
alachua, 
FL 
32615

Correspodent Contact dennis tomisaka
Regulation Number 888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received 04/07/2011
Decision Date 05/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls