Kelyniam Global, Inc.
Collinsville, CT, US
KELYNIAM GLOBAL INC. appears in FDA device records in Collinsville, CT. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Kelyniam Global, Inc. between 2011 and 2025. The busiest year on record is 2011, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2019 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | GWO | Substantially Equivalent | |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | GWO | Substantially Equivalent | |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | GXN | Substantially Equivalent | |
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | GXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009424796 | 3009424796 | KELYNIAM GLOBAL INC. | 97 RIVER RD STE A, COLLINSVILLE, CT 06019 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1873-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 | 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 | Class II | Terminated | |
| Z-1872-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 | 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 | Class II | Terminated | |
| Z-1871-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 | 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 | Class II | Terminated | |
| Z-1870-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | 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 | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain