FDA.reportPublic FDA data

WRISTAR MULTIAX

Primary DI
08056693027901
Brand
WRISTAR MULTIAX
Company
INTRAUMA SPA
Model
120.9036
Catalog number
120.9036
Device description
WRISTAR MultiAx Radius Volar Plate (R) Small-Long
Published
2025-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K252959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252959000WRISTAR MultiAx Distal Radius KitIntrauma S.P.A2025-11-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056693027901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056693027901080566930279018056693027901

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. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length64Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
387588051
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056693001352ELOS200.0001200.00012022-09-12
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
08056693002151MULTIAX SCREW120.2322120.23222025-11-27
08056693002168MULTIAX SCREW120.2324120.23242025-11-27
08056693002175MULTIAX SCREW120.2326120.23262025-11-27

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Primary DI, Brand, Company table
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