FDA.report

STAINLESS STEEL TIBIAL NAILING SYSTEM

Primary DI
18032568034776
Brand
STAINLESS STEEL TIBIAL NAILING SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
17473
Device description
NAIL RIGID REAMER D 8 MM LENGTH 410 MM
Published
2018-04-05
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

Related Records

Contact Domains

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18032568034776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1803256803477618032568034776

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length410Millimeter
Outer Diameter8Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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18059015376753TRUELOK SYSTEM50-251750-25172025-07-14
18052469476055MINI-FIXATION SYSTEMS1M1462022-12-27
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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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