INNOVATIVE STERILIZATION TECHN

FDA Device Registration & Listing · Dayton, OH, US · Registration 3010772758

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
3010772758
FEI Number
3010772758
Entity Name
INNOVATIVE STERILIZATION TECHN
City/State/Country
Dayton, OH, US
Establishment Address
7625 PARAGON RD STE A, Dayton, OH 45459, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Innovative Sterilization Technologies LLC (Owner Number: 10046120)
Owner / Operator Contact Address
7625 Paragon Rd, Suite A, Dayton, OH 45459, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213209
PMA Number
N/A

All Registered Proprietary Names

EZ TRAX Persona Knee Containment Device ONE TRAY EZ TRAX Stryker Mako Total Knee Containment Device ONE TRAY Sealed Sterilization Container System EZ TRAX Zimmer G7 Acetabular Taperloc Complete Hip System Containment Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-02-02
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-02-05
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-02-02
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-02-02
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-02-02

Official Correspondent

Scott Cohen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Innovative Sterilization Technologies 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
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010772758. Last updated year: 2026. Please use registration number 3010772758 when referencing this establishment in official correspondence.
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