Panels › Orthopedic › Product code HXI · Class 1
Passer, Wire, Orthopedic
Regulation 888.4540
0510(k)s in 12 months (3 all time)
1recalls in 12 months (8 all time)
2recalls that name a 510(k)
Top companies in HXI
| Company | 510(k)s | Recalls |
|---|---|---|
| EBI, L.P. | 0 | 3 |
| Bowen & Company, Inc. | 2 | 0 |
| Interventional Spine Inc | 0 | 2 |
| Extremity Medical LLC | 0 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Paragon 28, Inc. | 0 | 1 |
| Safewire, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2014 | K140576 | Y WIRE 2 Safewire, LLC | HXI |
| Sep 5, 1986 | K863148 | BOWEN KNOT PASSER Bowen & Company, Inc. | HXI |
| Sep 5, 1986 | K863146 | BOWEN SUTURE PASSER Bowen & Company, Inc. | HXI |
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