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510(k) K182677

DynaNail Mini by MedShape, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2019
Date Received
September 26, 2018
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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  • K203595 — DynaFuse Fixation System (January 4, 2022)
  • K203381 — Dynanail Mini Hybrid (January 15, 2021)
  • K193305 — DynaClip Bone Staple (April 23, 2020)
  • 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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