RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems— 510(k) K161210
Substantially EquivalentMedtronic Sofamor Danek
FDA 510(k) clearance K161210 for RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems, Substantially Equivalent on 2016-08-12. Applicant: Medtronic Sofamor Danek. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek
- Product code
- Code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code OUR
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- K173125 — T2 STRATOSPHERE Expandable Corpectomy System
- K172199 — ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- K171031 — CRESCENT Spinal System
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.