SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM


Device Classification Name

sacroiliac joint fixation

510(k) Number K111801
Device Name SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
Applicant
Zyga Technology, Inc.
700 10th avenue south,
suite 400
minneapolis, 
MN 
55415

Applicant Contact diane brinza
Correspondent
Zyga Technology, Inc.
700 10th avenue south,
suite 400
minneapolis, 
MN 
55415

Correspodent Contact diane brinza
Regulation Number 888.3040
Classification Product Code
OUR  
Date Received 06/27/2011
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