The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Response Bandloc Spinal Fixation.
| Device ID | K161267 |
| 510k Number | K161267 |
| Device Name: | Response BandLoc Spinal Fixation |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | ORTHOPEDIATRICS CORP. 2850 FRONTIER DRIVE Warsaw, IN 46538 |
| Contact | Mark Fox |
| Correspondent | Mark Fox ORTHOPEDIATRICS CORP. 2850 FRONTIER DRIVE Warsaw, IN 46538 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2016-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132150627 | K161267 | 000 |
| 00841132135914 | K161267 | 000 |
| 00841132124413 | K161267 | 000 |
| 00841132144664 | K161267 | 000 |
| 00841132144657 | K161267 | 000 |