SMITH & NEPHEW HYBRID KNEE FEMORAL— 510(k) K042896
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K042896 for SMITH & NEPHEW HYBRID KNEE FEMORAL, Substantially Equivalent on 2005-01-12. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code NPJ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Memphis, TN, US
Recent devices under product code NPJ
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- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code NPJ
product code NPJ- Injury
- 258
- Total
- 258
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.