Uss

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 24 Oct 2026.

Device Name

USS Bone Screw Pedicle Screw Vertebral Body Screw Cancellous Low Profile Polyaxial Perforated Side-Opening

Model / Reference

USS - Universal Spine System Bone Screw, 498.540

Primary DI / UDI-DI

07611819044036

Basic UDI-DI

7611819a00269JW

EMDN Code

P09070302 Thoracolumbosacral fixation systems

Device Class

Class IIb

EU market of registration

Belgium

EUDAMED SRN

CH-MF-000013345

Authorised representative

DePuy Ireland UC IE-AR-000009328

Category: Spinal bone screw, non-bioabsorbable

• Tomofix

  Class IIb

  CE/MDR

• Volt

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  CE/MDR

• Cannulated Screw Stainless Steel

  Class IIb

  CE/MDR

• Lc-Dcp

  Class I

  CE/MDR

• Va Lcp

  Class IIb

  CE/MDR

• Tomofix

  Class IIb

  CE/MDR

See all devices from Synthes GmbH →

• What is the USS Bone Screw designed to do in spinal surgery, and why is the polyaxial feature important?

  The USS Bone Screw is designed for vertebral body stabilization, providing low-profile fixation in spinal procedures. The polyaxial feature allows adjustable angles, accommodating anatomical variations in pedicle screw placement, which enhances flexibility and precision during surgery.

• Is the USS Bone Screw reusable, and how should it be handled to maintain sterility?

  No, the USS Bone Screw is a single-use, implantable device. Since it is supplied sterile, it must be handled according to strict sterile medical practices to prevent contamination before use.

• What sizes or models are available for the USS Bone Screw, and how can I identify the correct one for a procedure?

  The USS Bone Screw is available in a universal design under the model name *USS - Universal Spine System Bone Screw*. While specific dimensions or variants aren’t detailed here, the polyaxial and perforated side-opening features ensure adaptability to different anatomical needs. Always refer to surgical guidelines or consult with the manufacturer for precise sizing based on patient anatomy.

• How can I ensure traceability for the USS Bone Screw if it’s used in a procedure?

  The USS Bone Screw carries a Basic UDI (*7611819a00269JW*), which allows for full traceability throughout its lifecycle. This identifier helps track the device’s origin, batch, and regulatory compliance, ensuring accountability in clinical and administrative records.

• What regulatory pathways does the USS Bone Screw follow, and who manufactures it?

  The USS Bone Screw is manufactured by Synthes GmbH and follows regulatory authorizations including FDA 510K clearance, MDD, and MDR compliance. It is classified as Class IIb under EU regulations, indicating a higher-risk medical device requiring strict adherence to manufacturing and safety standards.