G3 40 Radiopaque Bone Cement

510(k) Number

K193061 ↗

FDA Product Code

LOD

FDA applicant

G21, S.R.L.

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical application for the G3 40 Radiopaque Bone Cement, and why is radiopacity important in this context?

  The G3 40 Radiopaque Bone Cement is specifically designed for vertebral augmentation and fixation procedures, such as spinal surgeries. Its radiopacity ensures clear visibility under X-ray imaging, which is critical for precise placement, monitoring of the procedure, and post-operative assessment of the implanted cement within the spine.

• Is the G3 40 Radiopaque Bone Cement intended for single-use or can it be reused after sterilization?

  The G3 40 Radiopaque Bone Cement is supplied as a sterile, single-use product. This design ensures patient safety by eliminating the risk of cross-contamination and maintaining sterility throughout its intended use in orthopedic settings.

• What regulatory pathways has the G3 40 Radiopaque Bone Cement undergone, and what does this mean for its use in clinical settings?

  The G3 40 Radiopaque Bone Cement has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. The FDA classification as a Class II device indicates it has undergone rigorous review by the Orthopedic (OR) Advisory Committee, ensuring it is suitable for vertebral augmentation and fixation procedures as intended.

• How is the G3 40 Radiopaque Bone Cement packaged, and what does this imply about its handling and storage?

  The G3 40 Radiopaque Bone Cement is supplied in a sterile, single-use packaging designed for orthopedic use. While the exact packaging details aren’t specified, the sterility and single-use nature imply it should be stored in a clean, dry environment, protected from moisture and extreme temperatures, and used immediately after opening to maintain its integrity and effectiveness.