TITANIUM GDLH POSTERIOR SPINAL SYSTEM— 510(k) K954645
Substantially Equivalent for Some IndicationsSofamor Danek USA,Inc.
FDA 510(k) clearance K954645 for TITANIUM GDLH POSTERIOR SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1996-01-16. Applicant: Sofamor Danek USA,Inc..
Clearance details
- Applicant
- Sofamor Danek USA,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.