Weber Permalock

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

510(k) Number

K896669 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SN

• Cementless Zweymueller Hip Endoprothes

  Class II

  FDA 510(k) K822979 Active Cleared 14 Jan 1983

• Biolox Ceramic Ball

  Class II

  FDA 510(k) K892644 Active Cleared 19 Oct 1989

• Centering Plug

  Class II

  FDA 510(k) K900392 Active Cleared 1 Mar 1990

• Zweymuller Cup

  Class III

  FDA 510(k) K851213 Active Cleared 28 May 1985

• Zweymueller-Sl Hip Prosthesis Stem

  Class III

  FDA 510(k) K871453 Active Cleared 13 Jul 1987

• Gsb Elbow

  Class II

  FDA 510(k) K901581 Active Cleared 22 Oct 1990

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• What is the Webber Permalock used for?

  The Webber Permalock is designed for orthopedic applications to secure bone fragments or implants in place, providing stability during the healing process. It is particularly useful in surgical settings where precise fixation is required, such as fracture repair or joint stabilization procedures. Its purpose is to maintain proper alignment and immobilization of skeletal structures, aiding in effective recovery.

• Is the Webber Permalock a single-use or reusable device?

  The Webber Permalock is supplied as a reusable medical device. This classification allows for multiple uses after proper cleaning and sterilization, which can be beneficial in reducing waste and costs in clinical settings. Always follow standard medical device reprocessing protocols to ensure safety and efficacy between uses.

• What regulatory approval does the Webber Permalock have?

  The Webber Permalock holds FDA 510(k) clearance under the reference number K896669. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device for some indications. The approval was granted under the traditional 510(k) review pathway, ensuring compliance with regulatory standards for orthopedic fixation hardware.

• Are there specific storage instructions for the Webber Permalock?

  The available data does not provide detailed storage instructions beyond standard medical device protocols. It is recommended to store the device in a clean, dry environment, protected from contamination and physical damage. Always adhere to manufacturer guidelines and facility protocols to maintain the device’s integrity and functionality.

• Does the Webber Permalock have any specific sterility or MRI safety information?

  The provided information does not include specific details regarding sterility or MRI safety for the Webber Permalock. If sterility is required for a procedure, it is essential to follow appropriate sterilization methods as recommended by the manufacturer or regulatory guidelines. For MRI safety, consult the device’s technical documentation or manufacturer to ensure compatibility with magnetic resonance imaging environments.