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510(k) K230690

Tandry Locking Plate System by Microware Precision Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2023
Date Received
March 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Microware Precision Co., Ltd.

  • K242814 — Tandry Q-Locking Plate System (November 14, 2024)
  • K220360 — Tandry CMF Plate System (November 10, 2022)
  • K220359 — Tandry Compression Screw System (September 20, 2022)
  • K182929 — BIO-RAY A-1 Anchor Screw System (November 6, 2019)
  • K171904 — Tandry Locking Plate System (September 18, 2018)
  • K111008 — MICROWARE BONE PLATES AND BONE SCREW (May 2, 2012)
  • K072562 — MICROWARE BONE PLATES AND BONE SCREWS (December 4, 2008)

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