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510(k) K192335

TRACKER Kyphoplasty System by GS Medical Co., Ltd. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2019
Date Received
August 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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