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510(k) K153296

MEDINAUT Kyphoplasty System by Imedicom Co., Ltd. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2016
Date Received
November 13, 2015
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

Other clearances by Imedicom Co., Ltd.

  • K182287 — MEDINAUT Plus (April 6, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K150915 — SPINAUT-P (March 18, 2016)
  • K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I (March 16, 2016)
  • K150789 — SPINAUT-E, SPINAUT-I (March 1, 2016)

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