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510(k) K101126

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS by Core Essence Orthopaedics, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2010
Date Received
April 22, 2010
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 Core Essence Orthopaedics, Inc.

  • K111716 — KNOTLESS SUTURE FIXATION SYSTEM (November 10, 2011)
  • K090128 — TAC-TITE (TM) (March 19, 2009)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K071477 — REVERTO 55 AND 37 SHAPE MEMORY STAPLES (August 15, 2007)
  • K071520 — RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X (August 10, 2007)

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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)