The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Axi+line Proximal Bunion Correction System.
| Device ID | K152548 |
| 510k Number | K152548 |
| Device Name: | AXI+LINE Proximal Bunion Correction System |
| Classification | Plate, Fixation, Bone |
| Applicant | NEXTREMITY SOLUTIONS, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Contact | Ryan Schlotterback |
| Correspondent | Ryan Schlotterback NEXTREMITY SOLUTIONS, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817701027065 | K152548 | 000 |
| 00817701020516 | K152548 | 000 |
| 00817701020523 | K152548 | 000 |
| 00817701020530 | K152548 | 000 |
| 00817701020547 | K152548 | 000 |
| 00817701020554 | K152548 | 000 |
| 00817701020561 | K152548 | 000 |
| 00817701020578 | K152548 | 000 |
| 00817701020585 | K152548 | 000 |
| 00817701020509 | K152548 | 000 |
| 00817701020493 | K152548 | 000 |
| 00817701028109 | K152548 | 000 |
| 00817701028116 | K152548 | 000 |
| 00817701028123 | K152548 | 000 |
| 00817701028130 | K152548 | 000 |
| 00817701028147 | K152548 | 000 |
| 00817701028154 | K152548 | 000 |
| 00817701028161 | K152548 | 000 |
| 00817701028178 | K152548 | 000 |
| 00817701020592 | K152548 | 000 |
| 00817701020608 | K152548 | 000 |
| 00817701020615 | K152548 | 000 |
| 00817701020721 | K152548 | 000 |
| 00817701020738 | K152548 | 000 |
| 00817701020745 | K152548 | 000 |
| 00817701020752 | K152548 | 000 |
| 00817701020769 | K152548 | 000 |
| 00817701020776 | K152548 | 000 |
| 00817701020783 | K152548 | 000 |
| 00817701020790 | K152548 | 000 |
| 00817701020714 | K152548 | 000 |
| 00817701020707 | K152548 | 000 |
| 00817701020622 | K152548 | 000 |
| 00817701020639 | K152548 | 000 |
| 00817701020646 | K152548 | 000 |
| 00817701020653 | K152548 | 000 |
| 00817701020660 | K152548 | 000 |
| 00817701020677 | K152548 | 000 |
| 00817701020684 | K152548 | 000 |
| 00817701020691 | K152548 | 000 |
| 00817701020806 | K152548 | 000 |