AME UNIVERSAL FIXATION SYSTEM— 510(k) K931381
Substantially Equivalent for Some IndicationsAmerican Medical Electronics, Inc.
FDA 510(k) clearance K931381 for AME UNIVERSAL FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1995-02-01. Applicant: American Medical Electronics, Inc..
Clearance details
- Applicant
- American Medical Electronics, Inc.
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Richardson, TX, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.