The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Response Bandloc Spinal Fixation.
| Device ID | K200097 |
| 510k Number | K200097 |
| Device Name: | Response BandLoc Spinal Fixation |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | OrthoPediatrics Corp. 2850 Frontier Drive Warsaw, IN 46582 |
| Contact | Jackie Jaskula |
| Correspondent | Jackie Jaskula OrthoPediatrics Corp. 2850 Frontier Drive Warsaw, IN 46582 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2020-03-16 |