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Kelyniam Global Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3009424796

Devices
1,838
Registrations
FDA
FDA recalls
4

What Kelyniam Global Inc. makes

Kelyniam Global Inc. manufactures non-alterable cranioplasty plates, designed for cranial reconstruction following trauma, surgery, or defect repair. These devices are intended to restore cranial integrity and protect underlying brain tissue.

The company’s cranioplasty plates are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number
3009424796
Address
97 RIVER RD STE A, COLLINSVILLE, CT, 06019

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 4 recalls initiated by KELYNIAM GLOBAL INC., initiated on 2017-06-10. By recorded status: 4 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 4
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2017

    • 10 Jun 2017 Z-1870-2018 Class II Terminated 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 Distribution: US nationwide distribution. Submission number: K103582
    • 10 Jun 2017 Z-1871-2018 Class II Terminated 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 Distribution: US nationwide distribution. Submission number: K103582
    • 10 Jun 2017 Z-1872-2018 Class II Terminated 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 Distribution: US nationwide distribution. Submission number: K103582
    • 10 Jun 2017 Z-1873-2018 Class II Terminated 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 Distribution: US nationwide distribution. Submission number: K103582

This is an FDA establishment record. No EUDAMED registration is known for this company.