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510(k) K211797

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2021
Date Received
June 10, 2021
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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  • K192335 — TRACKER Kyphoplasty System (December 4, 2019)
  • K190170 — MVP Cervical Plate System (May 13, 2019)

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  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)