ACPII ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K970806
Substantially Equivalent for Some IndicationsSofamor Danek USA,Inc.
FDA 510(k) clearance K970806 for ACPII ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent for Some Indications on 1997-05-02. Applicant: Sofamor Danek USA,Inc..
Clearance details
- Applicant
- Sofamor Danek USA,Inc.
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.