Meniscal Repair Device

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

510(k) Number

K981692 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• EndoPearl

  Class II

  FDA 510(k) K984171 Active Cleared 29 Apr 1999

• Trident Resection Ablator

  Class II

  FDA 510(k) K033748 Active Cleared 15 Dec 2003

• Linvatec 300W Xenon Light Source

  Class II

  FDA 510(k) K031994 Active Cleared 21 Aug 2003

• Cuto(Tm) Tissue Morcellation System

  Class I

  FDA 510(k) K932700 Active Cleared 15 Oct 1993

• El Lightwave Suction Ablator, Model El-2000-S, Lightwave Suction Ablator, Model Ia-2000-S, Lightwave Ablator, Model Ia-

  Class II

  FDA 510(k) K083281 Active Cleared 25 Feb 2009

• Resection Ablator

  Class II

  FDA 510(k) K013369 Active Cleared 4 Apr 2002

See all devices from Linvatec Corp. →

• What is the primary purpose of the Meniscal Repair Device?

  The Meniscal Repair Device is a surgical instrument specifically designed to facilitate the fixation of meniscal tears, which helps support the natural healing process of the tissue.

• Is the Meniscal Repair Device reusable or sterile?

  This device is supplied in a sterile condition and is intended for single-use applications only to ensure patient safety and prevent cross-contamination.

• What is the regulatory status of this device?

  The device has received FDA 510(k) clearance, which indicates that it has been determined to be substantially equivalent to legally marketed predicate devices for clinical use.