FDA Product Code
FDA Product Code HXI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4540
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140576 | Y WIRE 2 | Safewire, LLC | 2014-05-20 | Traditional | PDF ↗ |
| K863146 | BOWEN SUTURE PASSER | Bowen & Company, Inc. | 1986-09-05 | Traditional | PDF ↗ |
| K863148 | BOWEN KNOT PASSER | Bowen & Company, Inc. | 1986-09-05 | Traditional | PDF ↗ |
Product code HXI · Class I · Orthopedic. Data: openFDA.