Product code
KWR: Prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
FDA product code · Class III · Orthopedic
Key facts
| Product code | KWR |
|---|---|
| Device | Prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented |
| Device class | Class III |
| Regulation number | 888.3640 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96 |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 100–999 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