FORTROSS BONE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K110561
Device Name FORTROSS BONE VOID FILLER
Applicant
PIONEER SURGICAL TECHNOLOGY
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact david j collette
Correspondent
PIONEER SURGICAL TECHNOLOGY
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact david j collette
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 02/28/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No