MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020— 510(k) K021604
Substantially EquivalentOhio Medical Instrument Co., Inc.
FDA 510(k) clearance K021604 for MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020, Substantially Equivalent on 2002-07-29. Applicant: Ohio Medical Instrument Co., Inc..
Clearance details
- Applicant
- Ohio Medical Instrument Co., Inc.
- Product code
- Code HBL
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
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.