Syzygy Stabilization System

• • Terminated Z-0325-2018 FDA Class II ·initiated 7 Jul 2017

  Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

• • Terminated Z-0883-2017 FDA Class II ·initiated 22 Nov 2016 ·on shared 510(k) K153152

  The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K153152 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Amendia Stand-Alone Cervical System

  Class II

  FDA 510(k) K152972 Active Cleared 14 Jan 2016

• Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link

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  FDA 510(k) K132925 Active Cleared 11 Feb 2014

• Spartan S3 Facet System

  Unclassified

  FDA 510(k) K092568 Active Cleared 17 Nov 2009

• Optimus ALIF System

  Class II

  FDA 510(k) K160291 Active Cleared 18 Feb 2016

• Amendia Cervical Plate System

  Class II

  FDA 510(k) K152455 Active Cleared 15 Oct 2015

See all devices from Amendia, Inc. →