iTotal Family Reusable Instrument Tray
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170226 FDA 510(k)
- FDA Product Code
- KCT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iTotal Family Reusable Instrument Tray is a medical device designed for use in surgical procedures. It is a reusable tray that contains various instruments required for orthopedic surgeries.
The tray is supplied by Conformis, Inc. and is not single-use. It is intended for hospital settings and has received FDA 510(k) clearance with the product code KCT. The tray is available in various sizes and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the iTotal Family Reusable Instrument Tray used for?
This tray is designed to hold the various instruments required for orthopedic surgeries. It is intended for use in hospital surgical settings.
Is the iTotal Family Reusable Instrument Tray a single-use device?
No, the iTotal Family Reusable Instrument Tray is a reusable device. It is intended to be used multiple times, provided it is maintained and cleaned according to the manufacturer's instructions.
How is the iTotal Family Reusable Instrument Tray supplied?
The tray is supplied by Conformis, Inc. It is available in various sizes to accommodate different surgical needs.
What is the regulatory status of the iTotal Family Reusable Instrument Tray?
The iTotal Family Reusable Instrument Tray has received FDA 510(k) clearance with the product code KCT. The submission was reviewed by the General Hospital review panel.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170226 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K170226 24 fields · synced Sep 23, 2026