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

Staple Driver

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

HXJ is the FDA product code for Staple Driver, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HXJ
Device name
Staple Driver
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
6
Ingested recalls
2

Clearances, product code HXJ

By decision year
6 clearances under product code HXJ with a decision year between 1983 and 1997, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HXJ by decision year
YearClearances
19832
19841
19931
19961
19971

Applicants with the most clearances

Product code HXJ
Applicants holding the most 510(k) clearances under product code HXJ
ApplicantClearances
Influence, Inc.2
Instrument Makar, Inc.1
Micro Surgical Instruments Corp.1
Stryker Corp.1
Techmedica, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order