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

Orthosis, Moldable, Supportive, Skin Protective

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

MNE is the FDA product code for Orthosis, Moldable, Supportive, Skin Protective, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MNE
Device name
Orthosis, Moldable, Supportive, Skin Protective
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
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code MNE

By decision year
2 clearances under product code MNE with a decision year between 1978 and 1994, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MNE by decision year
YearClearances
19781
19941

Applicants with the most clearances

Product code MNE
Applicants holding the most 510(k) clearances under product code MNE
ApplicantClearances
Crown Delta Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order