AUGMENT POSTERIOR SPINAL FIXATION SYSTEM— 510(k) K922672
Substantially Equivalent for Some IndicationsSofamor Danek Mfg., Inc.
FDA 510(k) clearance K922672 for AUGMENT POSTERIOR SPINAL FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1993-05-18. Applicant: Sofamor Danek Mfg., Inc..
Clearance details
- Applicant
- Sofamor Danek Mfg., Inc.
- Product code
- Code KWP
- 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 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.