FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034647807
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5161-00-5145
Catalog number
5161005145
Device description
TRIALTIS Spine System Counter Torque, Power
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034647807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503464780710705034647807

GMDN Terms#

Term, Definition table
TermDefinition
Mastication muscle electrical stimulation systemAn assembly of devices designed to apply electrical stimuli to the mastication and facial muscles. It typically consists of an electrical pulse generator, appropriate active electrodes that are usually placed on the coronoid notches of the mandible, and a common return electrode located at the nape of the neck below the hairline. The device is typically used in dentistry to relax the facial and mastication muscles to treat temperomandibular joint (TMJ) dysfunction and associated pain, to relieve symptoms associated with muscle spasm, to take occlusal registrations and denture impressions, and for other therapeutic measures.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29
10705034608693TRIALTIS5560520310S5560520310S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07613327538939Prep PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539332Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539349Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539448Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327542134Bone Mill PlusSTRYKER CORPORATIONHWE2022-12-22
07613327467765EZoutSTRYKER CORPORATIONHWE2021-06-17
07613327467864PrecisionSTRYKER CORPORATIONHWE2021-06-17
07613327467819NASTRYKER CORPORATIONHWE2021-06-15
07613327467826NASTRYKER CORPORATIONHWE2021-06-15
07613327467833NASTRYKER CORPORATIONHWE2021-06-15
07613327467840NASTRYKER CORPORATIONHWE2021-06-15
07613327467857NASTRYKER CORPORATIONHWE2021-06-15
08800038040359Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040366Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040373Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17