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510(k) K203855

CoNextions TR Tendon Repair System by Conextions Medical — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2022
Date Received
December 31, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

Other clearances by Conextions Medical

  • K200028 — Coronet Soft Tissue Fixation System (March 4, 2020)

Other clearances for product code GAQ

  • K193209 — Wego-Stainless Steel (February 19, 2020)
  • K172146 — MERISTEEL (February 1, 2018)
  • K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture (November 1, 2017)
  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (May 28, 2014)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 2008)
  • K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (February 7, 2007)
  • K042606 — MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (May 27, 2005)
  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)