Washer, Bolt, Nut, Orthopedic

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

510(k) Number

K954682 ↗

FDA Product Code

HTN

Device Class

Class II

Regulation

21 CFR Part 888.3030

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 materials are these orthopedic washers, bolts, and nuts made from, and why does that matter in surgery?

  These devices are constructed from high-performance alloys including cobalt-chromium-molybdenum, stainless steel, or titanium. These materials are chosen for their strength, corrosion resistance, and biocompatibility, ensuring durability and minimizing the risk of adverse reactions during or after surgery. The choice of alloy also helps maintain structural integrity under the mechanical stresses of orthopedic fixation.

• Are these washers, bolts, and nuts intended for reuse in surgery, or are they meant to be used only once?

  These devices are explicitly designed for single-use in orthopedic surgery. Reuse is not recommended or supported, as single-use ensures sterility and reduces the risk of contamination or material degradation that could compromise patient safety or surgical outcomes.

• How are these washers, bolts, and nuts supplied, and what does that mean for surgical preparation?

  They are supplied sterile, which means they are pre-packaged and ready for immediate use in the operating room without additional sterilization. This ensures compliance with surgical protocols and minimizes the risk of intraoperative contamination, allowing surgeons to focus on the procedure without delays.

• What types of orthopedic implants are these washers, bolts, and nuts compatible with, and how do they function?

  These components are designed to secure metallic implants such as plates, nail/plate combinations, or blade/plate constructs. The washer, bolt, and nut assembly works together to distribute force evenly, preventing loosening or failure of the fixation hardware during bone healing. They are integral to maintaining stability in fractures or joint reconstructions.