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510(k) K191826

KeYi Total Hip System by Beijing Keyi Medical Device Technology Co., Ltd. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2020
Date Received
July 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Beijing Keyi Medical Device Technology Co., Ltd.

  • K230120 — KeYi Total Knee System (April 19, 2024)
  • K190567 — KeYi Spinal Fixation System (May 8, 2019)
  • K162380 — Locking Plate System (May 2, 2017)

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