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Product codes
ORY
Product code ORY
Device name
Tongue Suspension System
Medical specialty
Dental
Device class
2
Regulation number
872.5570
Review panel
DE
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K213159
Encore System
Siesta Medical, Inc.
2021-12-22
K201238
Encore System
Siesta Medical, Inc.
2020-10-02
K183310
Encore System
Siesta Medical, Inc.
2019-05-09
K133680
ENCORE SYSTEM
Siesta Medical, Inc.
2014-03-26
K121440
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
Siesta Medical, Inc.
2012-12-06
K121814
ENCORE TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
2012-11-07
K111179
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
Siesta Medical, Inc.
2011-07-01
K110127
PRELUDE III TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
2011-04-08
K103179
PRELUDE II TOUNGE SUSPENSION SYSTEM
Siesta Medical, Inc.
2010-12-20
K101060
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
Siesta Medical, Inc.
2010-07-08
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
00862211000206
Encore System
Siesta Medical
2015-12-07