SMALL BONE FIXATION SYSTEM— 510(k) K911929
Substantially EquivalentUnited American Medical Co., Inc.
FDA 510(k) clearance K911929 for SMALL BONE FIXATION SYSTEM, Substantially Equivalent on 1991-07-02. Applicant: United American Medical Co., Inc..
Clearance details
- Applicant
- United American Medical Co., Inc.
- Product code
- Code HWE
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mc Minnville, TN, US
Adverse events under product code HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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.