Navigated Cd Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K124004 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)
The Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, and Legacy Taps are orthopaedic instruments designed for spinal fixation procedures. These tools facilitate precise screw placement and bone preparation under surgical navigation, ensuring accurate implant alignment in pedicle screw systems. The set includes cannulated and non-cannulated taps, iliac taps, and legacy taps tailored for compatibility with specific screw systems. Their design supports minimally invasive techniques, enhancing procedural control and reducing surgical risks.
These instruments are supplied as reusable surgical tools and are intended for use in operating rooms during spinal surgeries. The set is compatible with the CD Horizon Legacy and Solera screw systems, as well as the IPC Powerease and NIM-Eclipse systems. No sterility claims are stated, but adherence to standard surgical instrument sterilisation protocols is implied. The devices are regulated under FDA 510(k) clearance (K124004) and fall under the Neurology advisory committee classification. Bench testing is noted as part of their validation process.
Frequently asked questions
What are the Navigated CD Horizon Solera Screwdrivers used for?
These screwdrivers, taps, iliac taps, and legacy taps are orthopaedic instruments specifically designed for spinal fixation procedures. They enable precise screw placement and bone preparation under surgical navigation, ensuring accurate alignment of pedicle screws in spinal surgeries. This precision supports minimally invasive techniques, improving procedural control and reducing surgical risks.
Are these instruments reusable or single-use?
The Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, and Legacy Taps are supplied as reusable surgical tools. They are intended for use in operating rooms during spinal surgeries and must adhere to standard surgical instrument sterilization protocols to maintain safety and efficacy.
Which screw systems are compatible with these instruments?
This set is designed for compatibility with the CD Horizon Legacy and Solera screw systems, as well as the IPC Powerease and NIM-Eclipse systems. The instruments are tailored to ensure proper fit and function with these specific spinal fixation systems, enhancing procedural efficiency.
Do these screwdrivers and taps come sterile?
No sterility claims are explicitly stated for these instruments. They are reusable tools intended to be sterilized according to standard surgical instrument protocols before each use. Always follow established sterilization guidelines to ensure safety and compliance.
What validation processes were used for these instruments?
The Navigated CD Horizon Solera instruments underwent bench testing as part of their validation process. This testing helps ensure the tools meet performance standards for precision, durability, and compatibility with their intended screw systems before clinical use.
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: Navigated Cd Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps ..., Medtronic Navigated CD Horizon Solera 6.5mm Tap (Cannulated) 9734302, NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS (K140454) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K124004 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA 510(k) K124004 24 fields · synced Oct 1, 2026