FDA.reportPublic FDA data

Alians Clavicle

Primary DI
03700569658984
Brand
Alians Clavicle
Company
NEWCLIP TECHNICS
Model
CBTGBA2D-ST
Catalog number
CBTGBA2D-ST
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170310000Alians Clavicle rangeNewclip Technics2017-03-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569658984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569658984037005696589843700569658984

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569621261Newclip InstrumentsANC306ANC3062026-05-11
03700569626181NACT2.8L60CT2.8L602024-11-14
03700569626198NACT2.8L60-STCT2.8L60-ST2024-11-14
03700569627553NACT3.5L38DCT3.5L38D2024-11-14
03700569628154NACT3.5L10D-STCT3.5L10D-ST2024-11-14
03700569628178NACT3.5L12D-STCT3.5L12D-ST2024-11-14
03700569628192NACT3.5L14D-STCT3.5L14D-ST2024-11-14
03700569628215NACT3.5L16D-STCT3.5L16D-ST2024-11-14
03700569628239NACT3.5L18D-STCT3.5L18D-ST2024-11-14
03700569628291NACT3.5L24D-STCT3.5L24D-ST2024-11-14
03700569628314NACT3.5L26D-STCT3.5L26D-ST2024-11-14
03700569644536NACT3.5L10DCT3.5L10D2024-11-14
03700569644543NACT3.5L12DCT3.5L12D2024-11-14
03700569644550NACT3.5L14DCT3.5L14D2024-11-14
03700569644567NACT3.5L16DCT3.5L16D2024-11-14
03700569644574NACT3.5L18DCT3.5L18D2024-11-14
03700569644604NACT3.5L24DCT3.5L24D2024-11-14
03700569647100NACT4.5L30D2024-11-14
03700569647117NACT4.5L30D-STCT4.5L30D-ST2024-11-14
03700569647124NACT4.5L35DCT4.5L35D2024-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255300866ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300873ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300880ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300897ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300903ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300910ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300927ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300934ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300941ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301634ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301641ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301658ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301665ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301672ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301689ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301696ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301702ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301719ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301726ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301931ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301948ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301955ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301962ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301979ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301986ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301993ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302006ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302013ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302020ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302037ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20