Data / Medical devices / United States / Kelyniam Global Inc.
Kelyniam Global Inc.: FDA-registered device maker in Collinsville, CT, United States, 4 510(k) clearances
Kelyniam Global Inc. is registered with the FDA (registration 3009424796) in Collinsville, CT, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 25, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009424796
- Address
- 97 River RD Ste A, Collinsville, CT, United States, 06019
- Owner or operator
- Kelyniam Global Inc. (10054881)
- Roles
- Manufacturer
- First device listed
- May 8, 2017
- Registered through
- 2027
- Brand names listed
- Customized Craniofacial Implant (CCI), Customized Craniofacial Implant (CCI) with Integrated Fixation System (IFS), Customized Skull Implant (CSI), Customized Skull Implant (CSI) with Integrated Fixation Systems (IFS), Fusion Craniofacial Implant (FCI), Fusion Skull Implant (FSI)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Cranioplasty, Preformed, Alterable | GWO | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2025 | K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | GWO | Substantially Equivalent | Kelyniam Global, Inc. | accessdata.fda.gov |
| May 21, 2019 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | GWO | Substantially Equivalent | Kelyniam Global, Inc. | accessdata.fda.gov |
| September 25, 2012 | K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | GXN | Substantially Equivalent | Kelyniam Global, Inc. | accessdata.fda.gov |
| April 14, 2011 | K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | GXN | Substantially Equivalent | Kelyniam Global, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2017 | 79791 | Class II | Terminated | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Cranioplasty, Preformed, Non-Alterable
- All makers of Plate, Cranioplasty, Preformed, Alterable
Updated July 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.