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510(k) Data Aggregation
K Number
K250072Device Name
CONDUIT SYNFIX Evolution Secured Spacer System
Manufacturer
Avalign Technologies, Inc.
Date Cleared
2025-07-10
(181 days)
Product Code
OVD
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Avalign Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K193066Device Name
Steripack cases and Tray Systems
Manufacturer
Avalign Technologies, Inc.
Date Cleared
2020-08-06
(276 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Avalign Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses.
The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Sterilization validation for the worst-case Steripack cases and tray system included surgical instrument such as rongeur forceps, endoscopes, wrenches, cutters, pliers, etc. The Steripack cases and tray system were validated for up to a 9.35 lb (4.24 kg) load of metal instruments and polymer handled instruments.
Device Description
Steripack Case and Tray Systems are utilized to secure medical instruments during transport, storage and processing (cleaning and sterilization). Orthopedic instruments and implants used in medical procedures are held in preconfigured cases and trays to facilitate transport to and from surgery and during cleaning and sterilization processes.
Some of the Case/Tray Systems in the Steripack line are preconfigured for a specific type instrument or surgical procedure. Other Cases/Trays in the Steripack line have components that are sold separately so the system can be configured based on the use.
Each Steripack Case and Tray Systems consist of multiple components designated to be integrated into a single unit. Which protects the interior components during the transportation, processing, and storage. All the component of the Steripack Case and Tray Systems are perforated with an evenly distributed hole pattern and are designed for stem sterilization. Since the Steripack Case and Tray Systems are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Steripack Case and Tray Systems are designed to be used with standard autoclaves used in the hospitals and healthcare facilities.
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