Orthofix, Inc. · Class II · Cleared Aug 31, 2021
| K-number | K211704 |
| Device name | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System |
| Applicant | Orthofix, Inc. |
| Product code | ODP |
| Device class | Class II |
| Decision date | Aug 31, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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