| Device |
prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
| Regulation Description |
Hip joint metal/polymer constrained cemented or uncemented prosthesis. |
| Definition |
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered. |
| Product Code | PBI |
| Regulation Number |
888.3310
|
|---|
| Device Class |
2
|
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