KELYNIAM GLOBAL INC.

FDA Device Registration & Listing · COLLINSVILLE, CT, US · Registration 3009424796

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009424796
FEI Number
3009424796
Entity Name
KELYNIAM GLOBAL INC.
City/State/Country
COLLINSVILLE, CT, US
Establishment Address
97 RIVER RD STE A, COLLINSVILLE, CT 06019, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Kelyniam Global Inc. (Owner Number: 10054881)
Owner / Operator Contact Address
97 River Rd, Ste 1, Canton, CT 06019, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250334
PMA Number
N/A

All Registered Proprietary Names

Customized Skull Implant (CSI) with Integrated Fixation Systems (IFS) Customized Craniofacial Implant (CCI) with Integrated Fixation System (IFS) Customized Craniofacial Implant (CCI) Fusion Skull Implant (FSI) Fusion Craniofacial Implant (FCI)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2020-04-09
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2017-05-08
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2025-12-29

Official Correspondent

Elise Bozzuto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kelyniam Global Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009424796. Last updated year: 2026. Please use registration number 3009424796 when referencing this establishment in official correspondence.
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