FDA.reportPublic FDA data

ILIZAROV SYSTEMS

Primary DI
08033201842072
Brand
ILIZAROV SYSTEMS
Company
MEDICALPLASTIC SRL
Model
71070341
Catalog number
71070341
Device description
ILIZAROV WIRE TENSIONER
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093047000SMITH & NEPHEW CIRCULAR FIXATION SYSTEMSmith & Nephew, Inc.2010-09-27KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033201842072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033201842072080332018420728033201842072

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, 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, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
434581062
Device count
1
Lot or batch
true
Serial number
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
08033201840993ILIZAROV SYSTEMS1006001006002016-09-30
08033201841006ILIZAROV SYSTEMS1006011006012016-09-30
08033201841013ILIZAROV SYSTEMS1007001007002016-09-30
08033201842324ILIZAROV SYSTEMS71013000710130002016-09-30
08033201842331ILIZAROV SYSTEMS71013002710130022016-09-30

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Primary DI, Brand, Company table
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10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
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B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16