AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System— 510(k) K202489
Substantially EquivalentAdvanced Orthopaedic Solutions, Inc.
FDA 510(k) clearance K202489 for AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System, Substantially Equivalent on 2020-10-26. Applicant: Advanced Orthopaedic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Orthopaedic Solutions, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrance, CA, US
Recent devices under product code HRS
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- K160409 — AOS Anterolateral Proximal Humeral Plate
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- K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.