QUADRANT RETRACTOR SYSTEM— 510(k) K043602
Substantially EquivalentMedtronic Sofamor Danek
FDA 510(k) clearance K043602 for QUADRANT RETRACTOR SYSTEM, Substantially Equivalent on 2005-02-23. Applicant: Medtronic Sofamor Danek. Device class: 1.
Clearance details
- Applicant
- Medtronic Sofamor Danek
- Product code
- Code GAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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- K171031 — CRESCENT Spinal System
Adverse events under product code GAD
product code GAD- Malfunction
- 504
- Total
- 504
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.