Synthes Acis/Vertebral Spacer Cr

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

510(k) Number

K120275 ↗

FDA Product Code

ODP

FDA applicant

Synthes (Usa), LLC

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What is the intended use of the Synthes ACIS/Vertebral Spacer CR?

  This device is a radiolucent cervical intervertebral body fusion implant designed to provide structural stability within the intervertebral disc space for skeletally mature individuals diagnosed with degenerative disc disease.

• How is the Synthes ACIS/Vertebral Spacer CR implanted?

  The device is implanted using an anterior surgical approach. It is intended to be used in conjunction with supplemental fixation to ensure proper stability during the fusion process.

• How is the fusion process supported by this device?

  To facilitate the fusion process, the interior of the spacer is designed to be packed with autogenous bone graft, which encourages bone growth and structural integration within the disc space.

• What is the regulatory status of this device?

  The Synthes ACIS and Vertebral Spacer CR has received FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.