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510(k) K083226

SMITH & NEPHEW PEEK INTERFERENCE SCREW by Smith & Nephew Endoscopy, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
November 3, 2008
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 Smith & Nephew Endoscopy, Inc.

  • K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS (February 3, 2011)
  • K102660 — BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS (December 13, 2010)
  • K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR (December 17, 2009)
  • K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (January 30, 2009)
  • K082095 — ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (October 21, 2008)
  • K050580 — SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (April 20, 2005)
  • K992396 — BIORCI SCREW (January 12, 2000)
  • K991500 — SMITH & NEPHEW SUTURE LOK (July 14, 1999)
  • K972599 — ACUFEX SCREW CANNULA (September 19, 1997)
  • K971939 — SMITH & NEPHEW SUTURE COLLET (August 6, 1997)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • 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)