MSD SILO SPINAL SYSTEM— 510(k) K042210
Substantially EquivalentMedtronic Sofamor Danek
FDA 510(k) clearance K042210 for MSD SILO SPINAL SYSTEM, Substantially Equivalent on 2004-11-04. Applicant: Medtronic Sofamor Danek. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek
- Product code
- Code MNI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code MNI
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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 MNI
product code MNI- Injury
- 641
- Total
- 641
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.