FDA.report

MULTIAX SCREW

Primary DI
08056693002151
Brand
MULTIAX SCREW
Company
INTRAUMA SPA
Model
120.2322
Catalog number
120.2322
Device description
MultiAx screw Ø 2.5 mm L.22 mm
Published
2025-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K252959000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K252959000WRISTAR MultiAx Distal Radius KitIntrauma S.P.A2025-11-12HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08056693002151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056693002151080566930021518056693002151

GMDN Terms

TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes

TypeValueUnit
Length22Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
387588051
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08056693000126INTRAUMA SURGICAL INSTRUMENTS205S2052025-11-27
08056693001949WRISTAR MULTIAXKM1.9031KM1.90312025-11-27
08056693001956WRISTAR MULTIAXKM1.9032KM1.90322025-11-27
08056693001963WRISTAR MULTIAXKM1.9033KM1.90332025-11-27
08056693001970WRISTAR MULTIAXKM1.9034KM1.90342025-11-27
08056693001987WRISTAR MULTIAXKM1.9035KM1.90352025-11-27
08056693001994WRISTAR MULTIAXKM1.9036KM1.90362025-11-27
08056693002007WRISTAR MULTIAXKM1.9037KM1.90372025-11-27
08056693002014WRISTAR MULTIAXKM1.9038KM1.90382025-11-27
08056693002083MULTIAX SCREW120.2308120.23082025-11-27
08056693002090MULTIAX SCREW120.2310120.23102025-11-27
08056693002106MULTIAX SCREW120.2312120.23122025-11-27
08056693002113MULTIAX SCREW120.2314120.23142025-11-27
08056693002120MULTIAX SCREW120.2316120.23162025-11-27
08056693002137MULTIAX SCREW120.2318120.23182025-11-27
08056693002144MULTIAX SCREW120.2320120.23202025-11-27
08056693002168MULTIAX SCREW120.2324120.23242025-11-27
08056693002175MULTIAX SCREW120.2326120.23262025-11-27
08056693002182MULTIAX SCREW120.2328120.23282025-11-27
08056693002199MULTIAX SCREW120.2330120.23302025-11-27

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