GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT— 510(k) K962557
Substantially Equivalent for Some IndicationsSmith & Nephew Richards, Inc.
FDA 510(k) clearance K962557 for GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1996-12-05. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Richards, Inc.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code JWH
view allMore clearances from Smith & Nephew Richards, Inc.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 →
Recalls naming K962557
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962557.
Data sourced from openFDA. This site is unofficial and independent of the FDA.