OrthoPediatrics Corp. · Class II · Cleared Mar 24, 2020
| K-number | K193100 |
| Device name | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System |
| Applicant | OrthoPediatrics Corp. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Mar 24, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
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