SPINE ALIGN
Device Facts
| Record ID | K801952 |
|---|---|
| Device Name | SPINE ALIGN |
| Applicant | B.H. Richardson, D.C. |
| Product Code | KYI · Orthopedic |
| Decision Date | Sep 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
