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510(k) K143473

Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles by Cayenne Medical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2015
Date Received
December 5, 2014
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 Cayenne Medical, Inc.

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  • K180274 — Ventix Link Knotless Anchor with Inserter (March 21, 2018)
  • K172186 — BioWick X Implant with Driver (October 16, 2017)
  • K161033 — AFX™ Femoral Implant With Inserter (August 3, 2016)
  • K151068 — SureLock W Suture Anchor (July 24, 2015)
  • K143392 — Quattro Bolt Tenodesis Screw (January 23, 2015)
  • K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH (December 30, 2013)
  • K131325 — QUATTRO GL SUTURE ANCHOR (August 16, 2013)
  • K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (October 31, 2012)
  • K122463 — APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH I (October 11, 2012)

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)