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

Apparatus, Traction, Non-Powered

21 CFR 888.5850 / Orthopedic
FDA source (opens on fda.gov)

HST is the FDA product code for Apparatus, Traction, Non-Powered, a class I device type, regulated under 21 CFR 888.5850. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
HST
Device name
Apparatus, Traction, Non-Powered
Regulation
21 CFR 888.5850
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
38
Ingested recalls
11

Clearances, product code HST

By decision year
38 clearances under product code HST with a decision year between 1977 and 2016, 1982 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HST by decision year
YearClearances
19771
19783
19795
19803
19813
19826
19833
19843
19864
19874
19991
20111
20161

Applicants with the most clearances

Product code HST
Applicants holding the most 510(k) clearances under product code HST
ApplicantClearances
Mizuho Orthopedic Systems Inc8
Lossing Orthopedic, Inc.3
Zimmer GmbH2
Comfortex, Inc.2
Acufex Microsurgical, Inc.1
American Health Tech., Inc.1
Back-On-Track, Inc.1
Ballert Orthopedic Corp.1
Danek Medical, Inc.1
Dyonics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 193 companies shown, in name order