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

Twister, Wire

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

HXS is the FDA product code for Twister, Wire, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HXS
Device name
Twister, Wire
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
2
Ingested recalls
2

Clearances, product code HXS

By decision year
2 clearances under product code HXS with a decision year between 1978 and 1983, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HXS by decision year
YearClearances
19781
19831

Applicants with the most clearances

Product code HXS
Applicants holding the most 510(k) clearances under product code HXS
ApplicantClearances
Bionic Instrument Corp.1
Orthopedic Equipment Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order