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

Splint, Hand, And Components

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

ILH is the FDA product code for Splint, Hand, And Components, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ILH
Device name
Splint, Hand, And Components
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
36
Ingested recalls
1

Clearances, product code ILH

By decision year
36 clearances under product code ILH with a decision year between 1976 and 1983, 1982 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code ILH by decision year
YearClearances
19765
19771
19783
19793
19803
19815
198212
19834

Applicants with the most clearances

Product code ILH
Applicants holding the most 510(k) clearances under product code ILH
ApplicantClearances
Fred Sammons, Inc.21
Conco Medical Co.5
Maddak, Inc.2
Warm & Form, Orthopedic Materials2
Alimed, LLC1
Zimmer GmbH1
Depuy, Inc.1
Mizuho Orthopedic Systems Inc1
Secol Co.1
Vermont Wood Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 422 companies shown, in name order