GENYSYS 22, LLC

FDA Device Registration & Listing · Warsaw, IN, US · Registration 3003740112

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
3003740112
FEI Number
3003740112
Entity Name
GENYSYS 22, LLC
City/State/Country
Warsaw, IN, US
Establishment Address
2466 N 200 W, Warsaw, IN 46580, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Genysys 22, LLC (Owner Number: 10094155)
Owner / Operator Contact Address
2466 N 200 W, Warsaw, IN 46580, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2025-11-18
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2025-11-18
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2025-11-18

Official Correspondent

John Barncard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Genysys 22, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K894785 Fdt Precision Machine Co., Inc. SURGICAL CHISEL/OSTEOTOME 1989-08-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003740112. Last updated year: 2026. Please use registration number 3003740112 when referencing this establishment in official correspondence.
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