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510(k) K220650

TriMed Ripcord Device by TriMed, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2022
Date Received
March 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K250948 — TriMed Fusion Cup System (April 8, 2025)
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Other clearances for product code HTN

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  • K243624 — Acu-Sinch Knotless Mini (January 23, 2025)
  • K242091 — Bolo Button System (December 23, 2024)
  • K243408 — TACTIX Vector Syndesmosis System (November 27, 2024)
  • K242311 — EXPERT - Flexible Joint Fixation System (November 1, 2024)
  • K240035 — TACTIX Vector Syndesmosis System (August 1, 2024)
  • K240947 — TENSOR® Suture Button System (June 3, 2024)
  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)