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510(k) K193108

Bonecam Suture Anchor by Valeris Medical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
November 8, 2019
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 Valeris Medical, Inc.

  • K192810 — Apollo Suture Anchor System (March 11, 2020)
  • K152255 — BoneCam Suture Anchors (November 16, 2015)
  • K142230 — Apollo Suture Anchor System and Titan Screws (September 10, 2014)

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)