# Kelyniam Global, Inc.

- Location (FDA's records): Canton, CT
- FDA decisions: 4 (2011–2025): 4 510(k) clearances
- Product codes: GWO (2), GXN (2)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- KLS-Martin L.P.: 2 (https://510kreport.com/company/kls-martin)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Osteosymbionics, LLC: 1 (https://510kreport.com/company/osteosymbionics)
- Vanduzen Dba Medcad: 1 (https://510kreport.com/company/vanduzen-dba-medcad)

## Firms that cite its devices most
- Oxford Performance Materials, Inc.: 1 (https://510kreport.com/company/oxford-performance-materials)
- 3D Systems, Inc.: 1 (https://510kreport.com/company/3d-systems)
- CraniUS, LLC: 1 (https://510kreport.com/company/cranius)

## Its most-cited devices
- K103582: Kelyniam Custom Skull Implant (Csi) (2011), cited by 4
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (2019), cited by 3
- K121755: Custom Craniofacial Implant (Cci) (2012), cited by 2

## Recent decisions
- K250334: Fusion Craniofacial Implant; Fusion Skull Implant (Jul 25, 2025)
- K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)
- K121755: Custom Craniofacial Implant (Cci) (Sep 25, 2012)
- K103582: Kelyniam Custom Skull Implant (Csi) (Apr 14, 2011)

Source page: https://510kreport.com/company/kelyniam-global