FDA.reportPublic FDA data

ILIZAROV SYSTEMS

Primary DI
28033201841765
Brand
ILIZAROV SYSTEMS
Company
MEDICALPLASTIC SRL
Model
102107
Catalog number
102107
Device description
1,8 MM DIA 400 MM LENGTH ST. STEEL WIRE WITH STOPPER, BAYONET POINT
Published
2016-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994143000SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]Smith & Nephew, Inc.2000-02-18JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28033201841765PrimaryGS10
08033201841761Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2803320184176528033201841765
08033201841761080332018417618033201841761

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
434581062
Device count
10
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28033201846890ILIZAROV SYSTEMS1021011021012025-08-20
28033201846906ILIZAROV SYSTEMS1021021021022025-08-20
28033201846913ILIZAROV SYSTEMS1021061021062025-08-20
28033201846920ILIZAROV SYSTEMS1021071021072025-08-20
08033201841716ILIZAROV SYSTEMS1021011021012025-08-20
08033201841723ILIZAROV SYSTEMS1021021021022025-08-20
08033201841754ILIZAROV SYSTEMS1021061021062025-08-20
08033201841761ILIZAROV SYSTEMS1021071021072025-08-20
08033201842416ILIZAROV SYSTEMS71012502710125022016-11-01
28033201841710ILIZAROV SYSTEMS1021011021012016-10-27
28033201841727ILIZAROV SYSTEMS 1021021021022016-10-27
08033201840795ILIZAROV SYSTEMS1001101001102016-10-07
08033201840801ILIZAROV SYSTEMS1001111001112016-10-07
08033201840818ILIZAROV SYSTEMS1001121001122016-10-07
08033201840993ILIZAROV SYSTEMS1006001006002016-09-30
08033201841006ILIZAROV SYSTEMS1006011006012016-09-30
08033201841013ILIZAROV SYSTEMS1007001007002016-09-30
08033201842324ILIZAROV SYSTEMS71013000710130002016-09-30
08033201842331ILIZAROV SYSTEMS71013002710130022016-09-30
08033201840702ILIZAROV SYSTEMS1001001001002016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386747407DOLPHIXCITIEFFE SRLJDW2025-04-02
08052990971893DOLPHIXCITIEFFE SRLJDW2024-10-28
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08905892004599GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004636GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDW2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDW2023-12-30
08720629950556ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950563ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950570ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950587ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
08720629950594ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14