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

Tongue Suspension System

21 CFR 872.5570 / Dental
FDA source (opens on fda.gov)

ORY is the FDA product code for Tongue Suspension System, a class II device type, regulated under 21 CFR 872.5570. FDA's definition for this code reads: "Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ORY
Device name
Tongue Suspension System
FDA definition
Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code ORY

By decision year
10 clearances under product code ORY with a decision year between 2010 and 2021, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ORY by decision year
YearClearances
20102
20112
20122
20141
20191
20201
20211

Applicants with the most clearances

Product code ORY
Applicants holding the most 510(k) clearances under product code ORY
ApplicantClearances
Siesta Medical, Inc.10

Companies listing this code with FDA

Companies whose registered establishments list this code