NB3D BONE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K111944
Device Name NB3D BONE VOID FILLER
Applicant
PIONEER SURGICAL TECHNOLOGY, INC.
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact floyd g larson
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC.
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact floyd g larson
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 07/08/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No