FDA Product Code
FDA Product Code NPJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3560
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015-03-10 | Special | PDF ↗ |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | Mako Surgical Corporation | 2013-12-10 | Special | PDF ↗ |
| K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | 2009-12-16 | Special | PDF ↗ |
| K093056 | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | Smith & Nephew, Inc. | 2009-12-15 | Traditional | PDF ↗ |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | Mako Surgical Corporation | 2009-06-17 | Traditional | PDF ↗ |
| K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | 2007-06-26 | Traditional | PDF ↗ |
| K061648 | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | DePuy Orthopaedics, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K061569 | SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS | Smith & Nephew, Inc. | 2006-07-06 | Special | PDF ↗ |
| K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 2005-12-27 | Traditional | PDF ↗ |
| K052265 | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL | Smith & Nephew, Inc. | 2005-12-27 | Abbreviated | PDF ↗ |
| K042896 | SMITH & NEPHEW HYBRID KNEE FEMORAL | Smith & Nephew, Inc. | 2005-01-12 | Abbreviated | PDF ↗ |
Product code NPJ · Class II · Orthopedic. Data: openFDA.