MEDULLARY CANAL SCRAPERS— 510(k) K811081
Substantially EquivalentThe Anspach Effort, Inc.
FDA 510(k) clearance K811081 for MEDULLARY CANAL SCRAPERS, Substantially Equivalent on 1981-04-29. Applicant: The Anspach Effort, Inc..
Clearance details
- Applicant
- The Anspach Effort, Inc.
- Product code
- Code HTO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code HTO
product code HTO- Injury
- 404
- Malfunction
- 20,305
- Total
- 20,709
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.