510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HXIClass I

Passer, Wire, Orthopedic

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

HXI is the FDA product code for Passer, Wire, Orthopedic, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
HXI
Device name
Passer, Wire, Orthopedic
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
8

Clearances, product code HXI

By decision year
3 clearances under product code HXI with a decision year between 1986 and 2014, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HXI by decision year
YearClearances
19862
20141

Applicants with the most clearances

Product code HXI
Applicants holding the most 510(k) clearances under product code HXI
ApplicantClearances
Bowen & Company, Inc.2
Safewire, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 148 companies shown, in name order