Z-PLATE ANTERIOR FIXATION SYSTEM— 510(k) K922543
Substantially Equivalent for Some IndicationsSofamor Danek Mfg., Inc.
FDA 510(k) clearance K922543 for Z-PLATE ANTERIOR FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1993-05-19. Applicant: Sofamor Danek Mfg., Inc..
Clearance details
- Applicant
- Sofamor Danek Mfg., 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.