The following data is part of a premarket notification filed by Orthopediatrics, Corp with the FDA for Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System.
| Device ID | K181390 |
| 510k Number | K181390 |
| Device Name: | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | OrthoPediatrics, Corp 2850 Frontier Drive Warsaw, IN 46582 |
| Contact | Mark Fox |
| Correspondent | Jackie Jaskula OrthoPediatrics, Inc 2850 Frontier Drive Warsaw, IN 46582 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-09-18 |
| Summary: | summary |