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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)
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Top companies in HXI

DateFirm and productCodeLinked 510(k)
Jul 17, 2026Paragon 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
HXINone listed
May 20, 2016Integra 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
HXINone listed
Mar 15, 2013Extremity 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
HXINone listed
Jul 1, 2011Interventional 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
HXINone listed
Jul 1, 2011Interventional 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
HXINone listed
Jun 22, 2005EBI, L.P.
Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
Terminated
HXIK982953
Jun 22, 2005EBI, L.P.
EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.
Terminated
HXINone listed
Jun 22, 2005EBI, L.P.
EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055.
Terminated
HXIK021786

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