FDA.reportPublic FDA data

CANNULATED SCREW SYSTEM

Primary DI
00889797037648
Brand
CANNULATED SCREW SYSTEM
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
03-4000-03
Catalog number
03-4000-03
Device description
Screw Length Measuring Plate
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797037648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797037648008897970376488897970376480889797037648

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

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Primary DI, Brand, Company table
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05055445928797SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928803SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928810SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928827SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928834SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
05055445928841SurtexSURTEX INSTRUMENTS LTD.FTY2026-05-12
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
04719846011786CharderCHARDER ELECTRONIC CO., LTD.FTY2026-04-29
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00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
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00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
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03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
04946585251672CROWNJUN Micro ScaleKONO SEISAKUSHO CO.,LTD.FTY2024-11-14
14026704920553KMEDICTELEFLEX INCORPORATEDFTY2024-07-15