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510(k) K190125

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire by T.A.G. Medical Products Corporation, Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2019
Date Received
January 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by T.A.G. Medical Products Corporation, Ltd.

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  • K230058 — Bladeless Trocar – Artemis Lap Cannula (April 28, 2023)
  • K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, Fiber (September 7, 2022)
  • K210498 — Betta Link Knotless Implant System (March 24, 2021)
  • K202178 — VersaLoop Anchor System (November 13, 2020)
  • K143326 — T.A.G. Dental Implant System (May 14, 2015)
  • K142653 — G-Lok and G-Lok XL Extender (October 16, 2014)
  • K113297 — KNOTILUS ANCHOR SYSTEM (March 2, 2012)
  • K112296 — LATERAL BUTTON (December 1, 2011)
  • K110763 — LATARJET CORTICAL SCREW SET (April 11, 2011)

Other clearances for product code MBI

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  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)