Kelyniam CSI PEEK-IM1003

• 4 recalls, same reason

  • Terminated Z-1873-2018 FDA Class II ·initiated 10 Jun 2017
  • Terminated Z-1871-2018 FDA Class II ·initiated 10 Jun 2017
  • Terminated Z-1872-2018 FDA Class II ·initiated 10 Jun 2017
  • Terminated Z-1870-2018 FDA Class II ·initiated 10 Jun 2017

  Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended

Trade Name

Kelyniam CSI

Generic Name

Cranioplasty plate, non-alterable

Model / Ref / Catalog

PEEK-IM1003

Primary DI / UDI-DI

00817580022694

510(k) Number

K103582 ↗

FDA Product Code

GXN

GMDN Term

Cranioplasty plate, non-alterable

Device Class

Class II

Regulation Number

882.5330

GUDID distribution status

Not in Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

MRI Safety

MR Safe

• Kelynaim CSI PEEK-IM1004

  Class II

  GUDID on market

• Kelyniam Csi Peek-IM1003

  Class II

  GUDID on market

• Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

  Class II

  FDA 510(k) K182711 Active Cleared 21 May 2019

• Fusion Craniofacial Implant; Fusion Skull Implant

  Class II

  FDA 510(k) K250334 Active Cleared 25 Jul 2025

• Kelyniam Custom Skull Implant (Csi)

  Class II

  FDA 510(k) K103582 Active Cleared 14 Apr 2011

• Custom Craniofacial Implant (Cci)

  Class II

  FDA 510(k) K121755 Active Cleared 25 Sep 2012

See all devices from Kelyniam Global Inc. →