Orthofix Medical, Inc. · Class II · Cleared Jun 20, 2024
| K-number | K240830 |
| Device name | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System |
| Applicant | Orthofix Medical, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jun 20, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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