EBI SMALL EXTERNAL FIXATOR (S/E/F/)— 510(k) K951357
Substantially Equivalent for Some IndicationsElectro-Biology, Inc.
FDA 510(k) clearance K951357 for EBI SMALL EXTERNAL FIXATOR (S/E/F/), Substantially Equivalent for Some Indications on 1995-06-21. Applicant: Electro-Biology, Inc..
Clearance details
- Applicant
- Electro-Biology, Inc.
- Product code
- Code KTT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.