INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)— 510(k) K994363
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K994363 for INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS), Substantially Equivalent on 2000-03-06. Applicant: Richard Wolf Medical Instruments Corp..
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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.