Ortho Tec, LLC · Class II · Cleared Mar 20, 2001
| K-number | K001535 |
| Device name | ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION |
| Applicant | Ortho Tec, LLC |
| Product code | KWP |
| Device class | Class II |
| Decision date | Mar 20, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 888.3050 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov