Product code
KXB: Prosthesis, hip, pelvifemoral resurfacing, metal/polymer
FDA product code · Class III · Orthopedic
Key facts
| Product code | KXB |
|---|---|
| Device | Prosthesis, hip, pelvifemoral resurfacing, metal/polymer |
| Device class | Class III |
| Regulation number | 888.3410 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in… |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database