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

Extractor

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

HWB is the FDA product code for Extractor, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HWB
Device name
Extractor
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
5
Ingested recalls
4

Clearances, product code HWB

By decision year
5 clearances under product code HWB with a decision year between 1978 and 1987, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HWB by decision year
YearClearances
19781
19801
19873

Applicants with the most clearances

Product code HWB
Applicants holding the most 510(k) clearances under product code HWB
ApplicantClearances
Arthropedics, Inc.1
Richard'S Medical Equip., Inc.1
Terray Manufacturing, Inc.1
The Anspach Effort, Inc.1
Warsaw Orthopedic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 252 companies shown, in name order