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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2026 | Paragon 28, Inc. P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle. Open, Classified |
HXI | None listed |
| May 20, 2016 | Integra LifeSciences Corp. K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System
The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. T Terminated |
HXI | None listed |
| Mar 15, 2013 | Extremity Medical LLC Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, Terminated |
HXI | None listed |
| Jul 1, 2011 | Interventional Spine Inc PERPOS PLS SYSTEM, CATALOG NO. 9045-02
A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid Terminated |
HXI | None listed |
| Jul 1, 2011 | Interventional Spine Inc PERPOS PLS SYSTEM, CATALOG NO. 9045-01
A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid Terminated |
HXI | None listed |
| Jun 22, 2005 | EBI, L.P. Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640. Terminated |
HXI | K982953 |
| Jun 22, 2005 | EBI, L.P. EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060. Terminated |
HXI | None listed |
| Jun 22, 2005 | EBI, L.P. EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055. Terminated |
HXI | K021786 |
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