FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
Device Facts
| Record ID | K010901 |
|---|---|
| Device Name | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B |
| Applicant | Disc-O-Tech Medical Technologies, Ltd. |
| Product Code | HSB · Orthopedic |
| Decision Date | Jun 19, 2001 |
| 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.
