Synergy Adjustable Transverse Connector Rod, Synergy Adjustable Transverse Connector Lamp

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

510(k) Number

K000876 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

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 is the purpose of the Synergy Adjustable Transverse Connector components?

  The Synergy Adjustable Transverse Connector Rod and Lamp are spinal pedicle fixation orthosis components. They are specifically engineered to provide necessary stabilization and structural support within the spinal column.

• What is the regulatory status of the Synergy spinal fixation components?

  These components are identified under FDA 510(k) clearance number K000876. This regulatory filing indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of the Synergy Adjustable Transverse Connector system?

  The Synergy Adjustable Transverse Connector system is manufactured by Interpore Cross Intl., based in Irvine, California. The system is classified under the orthopedic product code MNI.