FDA.reportPublic FDA data

STAINLESS STEEL TIBIAL NAILING SYSTEM

Primary DI
18032568034851
Brand
STAINLESS STEEL TIBIAL NAILING SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
17483
Device description
U-SHAPED STABILIZING SPACER 9/12 MM FOR TIBIAL NAIL
Published
2018-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18032568034851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803256803485118032568034851

GMDN Terms#

Term, Definition table
TermDefinition
Bone-nailing spacerA cylindrical rod-like device used as a precision reference to provide the correct spatial distance between an an intramedullary bone nail (femoral, humeral, tibial) to which it is interfaced, and an aiming arm, joining the two in a relative position. This procedure is performed to set-up the aiming arm prior to surgery; the set-up is dismantled and then reconnected after implantation of the nail with this device (the spacer) which is percutaneously introduced into a selected hole in the bone nail. It is typically made of high-grade stainless steel or synthetic materials. Several reference spacers may be used for this procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width31Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015376111Fitbone Trochanteric99-O4OL18B1099-O4OL18B102025-07-14
18059015376739TRUELOK SYSTEM50-251550-25152025-07-14
18059015376746TRUELOK SYSTEM50-251650-25162025-07-14
18059015376753TRUELOK SYSTEM50-251750-25172025-07-14
18052469476055MINI-FIXATION SYSTEMS1M1462022-12-27
18052469476086MINI-FIXATION SYSTEMS199-M1462022-12-27
18052469476406MINI-FIXATION SYSTEMS199-M14602022-12-27
18053504362852VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202082019-07-17
18053504362869VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202102019-07-17
18053504362876VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202122019-07-17
18053504362883VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202142019-07-17
18053504362890VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202162019-07-17
18053504362906VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202182019-07-17
18053504362913VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202202019-07-17
18053504362920VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202222019-07-17
18053504362937VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202242019-07-17
18053504362944VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202262019-07-17
18053504362951VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202282019-07-17
18053504362968VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202302019-07-17
18053504362975VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM1002-N-202322019-07-17

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