ADAPT for Gamma3
FDA 510(k)Class II (US FDA 510(k))
by Stryker GmbH
Identifiers
- 510(k) Number
- K173946 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ADAPT for Gamma3 is a surgical navigation system used during femur fracture surgery. It processes digital images from C-arms (including flat panel detectors) to assist surgeons in determining orthopedic implant size and positioning.
The system is operated by surgeons and clinic staff in clinical settings and integrates with the Stryker Navigation System. It is supplied as a reusable device and is MRI safe. The device has FDA 510K clearance with product code OLO and was authorized on 2018-05-02.
Frequently asked questions
What is the ADAPT for Gamma3 used for?
ADAPT for Gamma3 is a surgical navigation system specifically designed to assist surgeons during femur fracture surgery by processing digital images from C-arms to determine orthopedic implant size and positioning.
How is the ADAPT for Gamma3 supplied?
The ADAPT for Gamma3 is supplied as a reusable device that integrates with the Stryker Navigation System. It is MRI safe and operated by surgeons and clinic staff in clinical settings.
What is the regulatory status of the ADAPT for Gamma3?
The ADAPT for Gamma3 has FDA 510K clearance with product code OLO, authorized on May 2, 2018. It was determined to be substantially equivalent through the traditional clearance process.
Who manufactures the ADAPT for Gamma3?
The ADAPT for Gamma3 is manufactured by Stryker GmbH, located in Selzach, Solothurn, Switzerland. The device was developed to enhance precision in orthopedic implant procedures.
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. Sources consulted: ADAPT Elektronik GmbH, ADAPT for Gamma3 | Stryker, ADAPT for Gamma3 (K202749) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173946 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K173946 24 fields · synced Sep 22, 2026