ADAPT for Gamma3
FDA 510(k)Class II (US FDA 510(k))
by Stryker GmbH
Identifiers
- 510(k) Number
- K181848 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 software based instrumentation designed for use in Gamma3 surgery. The software assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal targeting.
It is supplied as a software system for use in the operating room. The device received FDA 510(k) clearance under K181848 with product code OLO and was found substantially equivalent via traditional review. It is not indicated as sterile, single-use, or reusable in the provided data, and no MRI safety, sizes, storage conditions, or additional authorisations are specified.
Frequently asked questions
What is ADAPT for Gamma3 used for?
ADAPT for Gamma3 is software-based instrumentation designed to assist surgeons during Gamma3 surgery with implant alignment, determining lag screw length, positioning lag screws, and distal targeting, as stated in the device description.
How is ADAPT for Gamma3 supplied for use?
ADAPT for Gamma3 is supplied as a software system intended for use in the operating room, according to the provided device data.
Is ADAPT for Gamma3 sterile, single-use, or reusable?
The device data does not indicate whether ADAPT for Gamma3 is sterile, single-use, or reusable; no such specifications are provided in the information given.
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, Gamma3 - Stryker, PDF ADAPT for Gamma3 Nailing redefined. - Tekno Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181848 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K181848 24 fields · synced Sep 26, 2026