BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Device Facts
| Record ID | K970897 |
|---|---|
| Device Name | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM |
| Applicant | Biodynamic Technologies, Inc. |
| Product Code | HSB · Orthopedic |
| Decision Date | Apr 21, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
