AOS PROXIMAL HUMERAL PLATE— 510(k) K080590
Substantially EquivalentAdvanced Orthopaedic Solutions, Inc.
FDA 510(k) clearance K080590 for AOS PROXIMAL HUMERAL PLATE, Substantially Equivalent on 2008-05-06. Applicant: Advanced Orthopaedic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Orthopaedic Solutions, Inc.
- Product code
- Code KTW
- 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 KTW
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Adverse events under product code KTW
product code KTW- Injury
- 220
- Total
- 220
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.