Skip to content

Kelyniam CSI PEEK-IM1003

by Kelyniam Global Inc. 266 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817580026500 UDI-DIDate22 Sep 2020ListedStatusListed GUDID: not in commercial distribution

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kelyniam CSI
Generic Name
Cranioplasty plate, non-alterable
Model / Ref / Catalog
PEEK-IM1003
Description
PEEK Customized Cranial Implant, Large CSI051220-LM1
Primary DI / UDI-DI
00817580026500
510(k) Number
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

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