DISCO SUBTALAR IMPLANT


Device Classification Name

screw, fixation, bone

510(k) Number K111834
Device Name DISCO SUBTALAR IMPLANT
Applicant
TRILLIANT SURGICAL LTD
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j d webb
Correspondent
TRILLIANT SURGICAL LTD
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j d webb
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/29/2011
Decision Date 12/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No