FDA 510(k) Application Details - K102907

Device Classification Name

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510(K) Number K102907
Device Name SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Applicant Zyga Technology, Inc.
700 10TH AVENUE SOUTH,
SUITE 400
MINNEAPOLIS, MN 55415 US
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Contact Diane Brinza
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Regulation Number

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Classification Product Code OUR
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Date Received 10/01/2010
Decision Date 12/14/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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