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510(k) K220359

Tandry Compression Screw System by Microware Precision Co., Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2022
Date Received
February 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Microware Precision Co., Ltd.

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  • 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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