Skip to content

Kelyniam Csi Peek-IM1004

by Kelyniam Global Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810125928086 UDI-DIDate6 Oct 2025ListedStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

4 recalls · FDA

  • 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

Specification

GUDID

Trade Name
Kelyniam Csi
Generic Name
Cranioplasty plate, non-alterable
Model / Ref / Catalog
PEEK-IM1004
Description
PEEK Customized Cranial Implant, X-LARGE CSI100325-FC1
Primary DI / UDI-DI
00810125928086
510(k) Number
FDA Product Code
GXN
GMDN Term
Cranioplasty plate, non-alterable
Device Class
Class II
Regulation Number
882.5330
Commercial Distribution
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Other devices from Kelyniam Global Inc.

See all devices from Kelyniam Global Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No