The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Response 5.5 Spine System.
| Device ID | K160466 |
| 510k Number | K160466 |
| Device Name: | Response 5.5 Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ORTHOPEDIATRICS CORP. 2850 FRONTIER DRIVE Warsaw, IL 46582 |
| Contact | Mark Fox |
| Correspondent | Mark Fox ORTHOPEDIATRICS CORP. 2850 FRONTIER DRIVE Warsaw, IL 46582 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132136478 | K160466 | 000 |
| 00841132136461 | K160466 | 000 |
| 00841132136454 | K160466 | 000 |
| 00841132136447 | K160466 | 000 |
| 00841132136430 | K160466 | 000 |
| 00841132136423 | K160466 | 000 |
| 00841132123942 | K160466 | 000 |
| 00841132123935 | K160466 | 000 |