NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K021336
Device Name NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
Original Applicant
NovaBone Products, LLC
one progress blvd.
suite 33
alachua, 
FL 
32615

Original Contact david m gaisser
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 04/26/2002
Decision Date 07/25/2002
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