Mitek Mini Anchor Modification

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K930892 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Mitek Drill Guide

  Class I

  FDA 510(k) K892904 Active Cleared 28 Sep 1989

• Mitek Super Quickanchor, Modification

  Class II

  FDA 510(k) K930893 Active Cleared 8 Dec 1993

• Braided Polyester Suture Material

  Class II

  FDA 510(k) K923161 Active Cleared 30 Dec 1992

• Mitek Toggle Anchor(Tm)

  Class II

  FDA 510(k) K950070 Active Cleared 22 May 1995

• Absorbalbe Anchor

  Class II

  FDA 510(k) K944051 Active Cleared 2 Aug 1995

• Mitek Ligament Anchor

  Class II

  FDA 510(k) K926270 Active Cleared 22 Oct 1993

See all devices from Mitek Surgical Products, Inc. →

• What types of orthopedic procedures is the Mitek Mini Anchor Modification specifically designed for?

  The Mitek Mini Anchor Modification is designed for ligament or tendon fixation to bone, which means it is used in procedures like ligament repair or reattachment. Its purpose is to provide a secure attachment between soft tissue (ligaments/tendons) and bone, commonly in orthopedic surgeries.

• Is the Mitek Mini Anchor Modification intended for reuse in surgical settings, or is it meant to be used only once?

  The device is explicitly intended for single-use only in sterile surgical settings. This ensures patient safety and maintains sterility standards during orthopedic procedures.

• How is the regulatory approval process for this device categorized, and what does that mean for its use?

  The Mitek Mini Anchor Modification received FDA 510(k) clearance under the Traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance allows it to be legally marketed and used in the U.S. for its intended orthopedic applications.

• Who is the manufacturer responsible for supplying this device, and where can it be obtained?

  The device is supplied by Mitek Surgical Products, Inc., based at 57 Providence Highway, Norwood, MA 02062. For inquiries or procurement, contact information is available through the manufacturer’s official channels.