AQUA Laminoplasty Systems

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

510(k) Number

K252930 ↗

FDA Product Code

NQW

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K243665 Active Cleared 31 Jan 2025

See all devices from ZheJiang Decans Medical Devices Co., Ltd. →

• What is the AQUA Laminoplasty Systems used for in spinal surgery?

  The AQUA Laminoplasty Systems is designed for laminoplasty procedures in cervical spine surgery. It stabilizes and supports vertebrae to maintain proper alignment and spacing, which helps decompress the spinal cord and nerve roots. This is particularly useful for addressing spinal stenosis or degenerative conditions where surgical reconstruction is required.

• How is the AQUA Laminoplasty Systems supplied, and what does this mean for clinical use?

  The AQUA Laminoplasty Systems is supplied sterile, ensuring it is ready for immediate use in the operating room without additional sterilization steps. This sterile packaging adheres to FDA-regulated standards, reducing the risk of infection and ensuring compliance with surgical protocols. The single-use nature of the device also minimizes cross-contamination risks between patients.

• Are there different models or reference codes for the AQUA Laminoplasty Systems, and why does this matter?

  Yes, the AQUA Laminoplasty Systems includes multiple reference codes (e.g., 3000270450, 3003935342) corresponding to specific model variants. These codes ensure traceability and regulatory compliance, allowing clinicians and institutions to identify the exact variant used in a procedure. This is critical for inventory management, recall tracking, and maintaining adherence to FDA guidelines.

• How should the AQUA Laminoplasty Systems be stored before use?

  While the exact storage instructions are not detailed in the provided data, sterile medical devices like the AQUA Laminoplasty Systems are typically stored in a clean, dry environment protected from moisture, dust, and extreme temperatures. The sterile packaging should remain intact until immediately before use to preserve sterility. Always follow the manufacturer’s specific storage guidelines, which may be included in the accompanying documentation.

• What regulatory pathway does the AQUA Laminoplasty Systems follow, and what does this mean for clinicians?

  The AQUA Laminoplasty Systems is authorized for marketing via FDA 510(k) clearance (K252930), determined to be substantially equivalent to predicate devices. This means the device has undergone rigorous review by the FDA to ensure it meets safety and effectiveness standards for its intended use in laminoplasty procedures. Clinicians can rely on this clearance as evidence of the device’s regulatory compliance and suitability for spinal fusion surgeries.