Kelyniam Global Inc.
Country not established 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.
Catalogue
Search and filter all 1,838 devicesShowing 1-50 of 1,838
Company details
- FDA FEI number
- 3009424796
- Address
- 97 RIVER RD STE A, COLLINSVILLE, CT, 06019
FDA recalls
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.
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
- 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
- 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
- 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
Frequently asked questions
How many devices does KELYNIAM GLOBAL INC. have in the registry?
The registry currently lists 1838 devices for KELYNIAM GLOBAL INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list KELYNIAM GLOBAL INC.'s devices?
Among its 50 most recently registered devices, KELYNIAM GLOBAL INC. has devices listed in FDA GUDID (50 devices).
What risk classes do KELYNIAM GLOBAL INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for KELYNIAM GLOBAL INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for KELYNIAM GLOBAL INC.?
FDA recall records list 4 recalls initiated by KELYNIAM GLOBAL INC., the most recent initiated on 2017-06-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from KELYNIAM GLOBAL INC. in the registry?
The most recently registered devices listed for KELYNIAM GLOBAL INC. include CUSTOMIZED SKULL IMPLANT (CSI) PEEK-IM1003, CUSTOMIZED SKULL IMPLANT (CSI) PEEK-IM1002, CUSTOMIZED SKULL IMPLANT (CSI) PEEK-IM1004 and FUSION SKULL IMPLANT FUSION-IM3004.