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

Tap, Bone

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

HWX is the FDA product code for Tap, Bone, 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 15 recalls.

Classification record

Product code
HWX
Device name
Tap, Bone
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
15

Clearances, product code HWX

By decision year
2 clearances under product code HWX with a decision year between 1984 and 1987, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HWX by decision year
YearClearances
19841
19871

Applicants with the most clearances

Product code HWX
Applicants holding the most 510(k) clearances under product code HWX
ApplicantClearances
Amtech Scientific, Inc.1
Buckman Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 272 companies shown, in name order