Preloaded Soft Tissue Anchor

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

510(k) Number

K953954 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

• 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 clinical use for the Preloaded Soft Tissue Anchor?

  This device is designed specifically for orthopedic procedures that require the attachment of soft tissue to bone. It is important to note that it is not intended for use in anterior or posterior cruciate ligament repair or reconstruction.

• What is the regulatory status of this Linvatec anchor?

  The Preloaded Soft Tissue Anchor has received FDA 510(k) clearance under the number K953954. It is categorized under product code MBI for orthopedic applications and was determined to be substantially equivalent for its intended indications.

• Who is the manufacturer of this soft tissue anchor?

  The device is manufactured by Linvatec Corp., located in Largo, Florida. They are the official applicant for the 510(k) clearance associated with this specific orthopedic product.