Medtronic Orthopaedic Trauma Application
FDA 510(k) K050651 · Medtronic Navigation, Inc.
510(k) numberK050651
Submission
- Device name
- Medtronic Orthopaedic Trauma Application
- Applicant
- Medtronic Navigation, Inc.
Louisville, CO, US - Received
- March 14, 2005
- Decision date
- July 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
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More from Claronav
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| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | 03/26/2026SE |
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| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationOLO · Traditional | 02/12/2026SE |
| K251282 | StealthStation S8 Spine SoftwareOLO · Traditional | 10/17/2025SE |
| K242464 | Stealth Spine Clamps; ModuLeX Shank MountsOLO · Traditional | 06/05/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | 05/29/2025SE |
| K240465 | O-arm O2 Imaging SystemOWB · Traditional | 06/21/2024SE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585)HAW · Traditional | 10/19/2023SE |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW · Traditional | 06/10/2022SE |
Questions and answers
When was Medtronic Orthopaedic Trauma Application cleared by the FDA?
Medtronic Orthopaedic Trauma Application (K050651) received a 510(k) decision of Substantially Equivalent on July 27, 2005, 135 days after the submission was received.
What is the product code of K050651?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.