FDA.report

Cut Screw - Percutaneous Compression Screw

Primary DI
07899258604794
Brand
Cut Screw - Percutaneous Compression Screw
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Cut Screw
Catalog number
317-04-16
Device description
CUT SCREW Ø4.0 x 16.0mm
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

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K230397000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258604794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899258604794078992586047947899258604794

GMDN Terms

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
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

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07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
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07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
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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
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