Interpore Cross International Occipito-Cervico-Thoracic Rod and Plate System

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

Full name

Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System

510(k) Number

K022048 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Altius Oct System

  Class II

  FDA 510(k) K033961 Active Cleared 14 Apr 2004

• Modification to Synergy Spinal System

  Class II

  FDA 510(k) K010515 Active Cleared 22 Mar 2001

• Pro Osteon Implant 500R Resorbable Bone Graft Substitute

  Class II

  FDA 510(k) K990131 Active Cleared 2 Mar 1999

• Ti Fenestrated Plate

  Class II

  FDA 510(k) K031772 Active Cleared 5 Sep 2003

• Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Models 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

  Class II

  FDA 510(k) K020204 Active Cleared 21 Feb 2002

• Synergy Adjustable Length Rod

  Class II

  FDA 510(k) K990057 Active Cleared 28 Jun 1999

See all devices from Interpore Cross Intl. →

• What types of spinal conditions is the ICI OCT Rod and Plate System specifically designed to address in the occipito-cervico-thoracic region?

  The ICI OCT Rod and Plate System is designed to stabilize and promote spinal fusion for conditions like degenerative disc disease, spondylolisthesis, or spinal instability affecting the occipito-cervico-thoracic junction. It targets the cervical spine and upper thoracic segments to restore alignment and structural integrity in these areas.

• Is the ICI OCT Rod and Plate System intended for reuse in surgical settings, or is it meant to be used only once?

  The ICI OCT Rod and Plate System is explicitly supplied as a sterile, single-use orthopedic implant. This means it must be discarded after one surgical procedure to maintain sterility and prevent contamination, adhering to standard medical device protocols for implants.

• What materials are used in the construction of the ICI OCT Rod and Plate System, and why does this matter?

  The system is constructed from titanium, a material chosen for its biocompatibility, strength, and corrosion resistance. Titanium is commonly used in spinal implants because it integrates well with bone tissue, reduces the risk of allergic reactions, and maintains structural integrity over time.

• How is the ICI OCT Rod and Plate System packaged and prepared for surgical use, and what precautions should be taken?

  The system is supplied in a sterile configuration, ready for immediate surgical use. It must be handled using sterile techniques to prevent contamination. Since it is intended for open surgical techniques, the packaging ensures sterility is maintained until the moment of implantation, requiring adherence to aseptic protocols during setup and procedure.

• Are there any restrictions on using the ICI OCT Rod and Plate System in environments with magnetic resonance imaging (MRI) equipment?

  The device does not have any noted MRI compatibility restrictions, meaning it can be used in patients who require MRI scans post-surgery. However, clinicians should always verify compatibility with specific MRI machines and protocols, as individual facility settings may vary.