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

Screwdriver

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

HXX is the FDA product code for Screwdriver, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 32 recalls.

Classification record

Product code
HXX
Device name
Screwdriver
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
4
Ingested recalls
32

Clearances, product code HXX

By decision year
4 clearances under product code HXX with a decision year between 1986 and 1990, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HXX by decision year
YearClearances
19861
19872
19901

Applicants with the most clearances

Product code HXX
Applicants holding the most 510(k) clearances under product code HXX
ApplicantClearances
Buckman Co., Inc.1
Dalton Technology, Inc.1
Med-Tool, Inc.1
W. L. Gore & Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 433 companies shown, in name order