POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES— 510(k) K080617
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K080617 for POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES, Substantially Equivalent on 2008-06-27. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.