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510(k) K203595

DynaFuse Fixation System by MedShape, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2022
Date Received
December 9, 2020
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 MedShape, Inc.

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  • K203381 — Dynanail Mini Hybrid (January 15, 2021)
  • K193305 — DynaClip Bone Staple (April 23, 2020)
  • K182677 — DynaNail Mini (February 14, 2019)
  • K181781 — DynaClipTM Bone Staple (November 5, 2018)
  • K171376 — DynaNail TTC Fusion System (November 2, 2017)
  • K141420 — FASTFORWARD (December 18, 2014)
  • K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREW (September 29, 2014)

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