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

File, Bone, Surgical

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

EMI is the FDA product code for File, Bone, Surgical, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
EMI
Device name
File, Bone, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
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
4

Clearances, product code EMI

By decision year
4 clearances under product code EMI with a decision year between 1983 and 1992, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EMI by decision year
YearClearances
19831
19851
19911
19921

Applicants with the most clearances

Product code EMI
Applicants holding the most 510(k) clearances under product code EMI
ApplicantClearances
Artiberia1
Biomedical Composites, Ltd.1
Today'S Machining & Design, Inc.1
Wilde-USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 143 companies shown, in name order