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510(k) K181781

DynaClipTM Bone Staple by MedShape, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2018
Date Received
July 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K203595 — DynaFuse Fixation System (January 4, 2022)
  • K203381 — Dynanail Mini Hybrid (January 15, 2021)
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  • K182677 — DynaNail Mini (February 14, 2019)
  • K171376 — DynaNail TTC Fusion System (November 2, 2017)
  • K141420 — FASTFORWARD (December 18, 2014)
  • K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREW (September 29, 2014)

Other clearances for product code JDR

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  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)