CLEARED UNDER GRAFTON II EDBM— 510(k) K122513
Substantially EquivalentMedtronic Sofamor Danek, Inc.
FDA 510(k) clearance K122513 for CLEARED UNDER GRAFTON II EDBM, Substantially Equivalent on 2013-03-06. Applicant: Medtronic Sofamor Danek, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek, Inc.
- Product code
- Code MBP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code MBP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.