METASURG DIGIFUSE IMPLANT


Device Classification Name

screw, fixation, bone

510(k) Number K111536
Device Name METASURG DIGIFUSE IMPLANT
Applicant
METASURG
16350 park ten pl., suite 101
houston, 
TX 
77084

Applicant Contact joshua scott
Correspondent
METASURG
16350 park ten pl., suite 101
houston, 
TX 
77084

Correspodent Contact joshua scott
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/02/2011
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No