CSCO Forehead Fixation System

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

510(k) Number

K963502 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Corp. →

• What is the CSCO Forehead Fixation System used for?

  The CSCO Forehead Fixation System is designed specifically for endoscopic forehead or brow lift procedures. It provides secure attachment of soft tissues during minimally invasive surgeries, enabling smaller incisions compared to traditional methods. This reduces scarring and minimizes blood loss by allowing endoscopic access through tiny openings, making it ideal for reconstructive or aesthetic forehead procedures.

• How is the CSCO Forehead Fixation System supplied and intended for use?

  The system is supplied sterile and is intended for single-use only. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and performance. Always follow sterile medical device protocols for storage and handling to preserve its condition before use.

• Is the CSCO Forehead Fixation System reusable or disposable?

  The CSCO Forehead Fixation System is explicitly designed for single-use. Reusing it is not recommended due to potential contamination risks and degradation of material properties over time, which could compromise patient safety and surgical outcomes.

• What regulatory pathway does the CSCO Forehead Fixation System follow?

  The device was cleared through the FDA’s 510(k) process under the Orthopedic Advisory Committee, classified as a Class II medical device. It falls under the MBI product code category for soft tissue fixation fasteners and was granted clearance via a traditional review pathway (K963502).

• How should the CSCO Forehead Fixation System be stored?

  Storage must comply with sterile medical device protocols to ensure the system remains intact and uncontaminated before use. This includes protecting it from moisture, physical damage, and exposure to temperatures outside the manufacturer’s specified range. Always follow the manufacturer’s instructions for optimal preservation.