SYNDE-LOCK SYNDESMOSIS REPAIR KIT


Device Classification Name

screw, fixation, bone

510(k) Number K111971
Device Name SYNDE-LOCK SYNDESMOSIS REPAIR KIT
Applicant
TARSUS MEDICAL INC.
465 fairchild drive suite 230
mountain view, 
CA 
94043

Applicant Contact nicholas mourlas
Correspondent
TARSUS MEDICAL INC.
465 fairchild drive suite 230
mountain view, 
CA 
94043

Correspodent Contact nicholas mourlas
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received 07/11/2011
Decision Date 01/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No