FDA.reportPublic FDA data

AIRvance™

Primary DI
00643169062979
Brand
AIRvance™
Company
MEDTRONIC XOMED, INC.
Model
76353200M
Device description
BONE SCREW 76353200M AIRVANCE SYSTEM
Published
2016-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, anti-snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981677000REPOSE BONE SCREW SYSTEMInfluence, Inc.1999-08-27LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169062979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169062979006431690629796431690629790643169062979

GMDN Terms#

Term, Definition table
TermDefinition
Sleep apnoea tongue implant, non-bioabsorbableA sterile device intended to be implanted into the tongue to help increase airway patency by anterior advancement and physical stabilization of the tongue in the management of obstructive sleep apnoea (OSA). It is in the form of a non-bioabsorbable looped thread implanted in the base of the tongue, attached anteriorly to the mandible with a bone anchor. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D854413871967328267319ApnoDentSELANE PRODUCTS, INC.LRK2026-05-29
00860005753093Serena SureSERENA SLEEP SOLUTIONS LLCLRK2026-05-20
00851085006247Nylon flexTAP Oral ApplianceAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
00851085006254Nylon flexTAP Oral Appliance KitAIRWAY TECHNOLOGIES, LLCLRK2026-05-08
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473777EMA Dual LaminateEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652110Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652127Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00850085577009Serena Fixed HingeSERENA SLEEP SOLUTIONS LLCLRK2026-03-30
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25