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510(k) K111399

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 by Arthrocare Corp. — Product Code MBI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 20, 2011
Date Received: May 19, 2011
Clearance Type: Special
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 Arthrocare Corp.

K153186 — Adjustable Fixation Device (January 28, 2016)
K131709 — SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (October 4, 2013)
K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR (February 27, 2013)
K111397 — TITAN TI SUTURE ANCHOR SYSTEM (July 12, 2011)
K110781 — 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTR (May 27, 2011)
K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (February 16, 2011)
K110164 — 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL (February 7, 2011)
K101437 — SPEEDFIX SUTURE SYSTEM (October 29, 2010)
K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (October 21, 2010)
K100479 — PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (September 21, 2010)

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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)