Carlsmed, Inc. · Class II · Cleared Sep 20, 2024
| K-number | K241332 |
| Device name | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device |
| Applicant | Carlsmed, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Sep 20, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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