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

Driver, Prosthesis

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

HWR is the FDA product code for Driver, Prosthesis, 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 6 recalls.

Classification record

Product code
HWR
Device name
Driver, Prosthesis
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
6

Clearances, product code HWR

By decision year
4 clearances under product code HWR with a decision year between 1987 and 1992, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HWR by decision year
YearClearances
19872
19881
19921

Applicants with the most clearances

Product code HWR
Applicants holding the most 510(k) clearances under product code HWR
ApplicantClearances
Warsaw Orthopedic, Inc.2
Buckman Co., Inc.1
Kim-Med, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 153 companies shown, in name order