COFIED MODULAR SHOULDER SYSTEM— 510(k) K955767
Substantially Equivalent for Some IndicationsSmith & Nephew Richards, Inc.
FDA 510(k) clearance K955767 for COFIED MODULAR SHOULDER SYSTEM, Substantially Equivalent for Some Indications on 1996-04-08. Applicant: Smith & Nephew Richards, Inc..
Clearance details
- Applicant
- Smith & Nephew Richards, Inc.
- Product code
- Code KWS
- 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 KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.