FDA.reportPublic FDA data

ILIZAROV SYSTEMS

Primary DI
08033201840993
Brand
ILIZAROV SYSTEMS
Company
MEDICALPLASTIC SRL
Model
100600
Catalog number
100600
Device description
WIRE FIXATION BOLT CANNULATED
Published
2016-09-30
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
28033201840997PackageGS15In Commercial Distribution
08033201840993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2803320184099728033201840997
08033201840993080332018409938033201840993

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
434581062
Device count
1
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
28033201841765ILIZAROV SYSTEMS1021071021072016-10-27
08033201840795ILIZAROV SYSTEMS1001101001102016-10-07
08033201840801ILIZAROV SYSTEMS1001111001112016-10-07
08033201840818ILIZAROV SYSTEMS1001121001122016-10-07
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
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08905892004667GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004711GPCGPC MEDICAL LIMITEDJDW2024-01-31
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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
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