ACE 6.5 MM BONE SCREW— 510(k) K931652
Substantially Equivalent for Some IndicationsAce Medical Co.
FDA 510(k) clearance K931652 for ACE 6.5 MM BONE SCREW, Substantially Equivalent for Some Indications on 1994-04-28. Applicant: Ace Medical Co..
Clearance details
- Applicant
- Ace Medical Co.
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.