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

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

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