FDA.reportPublic FDA data

Cut Screw - Percutaneous Compression Screw

Primary DI
07899258605005
Brand
Cut Screw - Percutaneous Compression Screw
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Cut Screw
Catalog number
317-04-58
Device description
CUT SCREW Ø4.0 x 58.0mm
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230397000Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.2023-06-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258605005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258605005078992586050057899258605005

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258695846Meniscus VersaflexMeniscus Versaflex354-3002026-03-03
07901125601062Meniscus VersaflexMeniscus Versaflex - Reverse354-4002026-03-03
07899258602011Orthopedic InstrumentsTHREADED OLIVE WIRE Ø1.2x60.0mm308-9152026-02-26
07901125601079Orthopedic InstrumentsCASE - COMPRESSION PLATES IMPLANTS AND INSTRUMENTS308-ES-FU2026-02-26
07899258602028Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø1,5MM308-9032026-02-20
07899258602035Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø2,0MM308-9092026-02-20
07899258638973Orthopedic InstrumentsBACAUS CANNULATED FORCEPS900-1502026-02-20
07899258639062Orthopedic InstrumentsPeriostum 4.0mm Straight Tip900-992026-02-20
07899258648057Orthopedic InstrumentsHOHMANN SEPARATOR 8.0mm900-1012026-02-20
07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
07899258660929Orthopedic InstrumentsHex wrench 4.0353-109-10352026-02-20
07899258660936Orthopedic Instruments3.5 hex wrench353-109-10362026-02-20
07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
07899258660950Orthopedic Instruments2.5 Hex Wrench353-109-10382026-02-20
07899258660967Orthopedic InstrumentsHex wrench 2.0353-109-10392026-02-20
07899258660974Orthopedic InstrumentsHex wrench 1.5353-109-10402026-02-20
07899258660981Orthopedic Instruments5.0 Hex wrench353-109-10332026-02-20
07899258660998Orthopedic Instruments5.5 Hex Wrench353-109-10322026-02-20
07899258694702Orthopedic InstrumentsTorxdrive Wrench T20353-109-10222026-02-20
07899258694719Orthopedic InstrumentsTorxdrive Wrench T18353-109-10232026-02-20

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