POLYFUSE – NEUROBONE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K111018
Device Name POLYFUSE – NEUROBONE
Applicant
ATPAC MEDICAL LLC
848 n rainbow blvd
las vegas, 
NV 
89107

Applicant Contact gary malinowski
Correspondent
ATPAC MEDICAL LLC
848 n rainbow blvd
las vegas, 
NV 
89107

Correspodent Contact gary malinowski
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 04/12/2011
Decision Date 02/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No