CEMEX SYSTEM GUN APPLICATION VERSION

• K Number: K000943
• Device Name: CEMEX SYSTEM GUN APPLICATION VERSION
• Manufacturer: EXACTECH, INC.
• Date Cleared: 2001-02-08 ( 322 days)
• Product Code: LOD
• Regulation Number: 888.3027
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”