FDA.reportPublic FDA data

Stainless Steel Femoral Nailing System

Primary DI
18032568034059
Brand
Stainless Steel Femoral Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
17326
Device description
DRILL BIT DIAMETER 6 MM LENGTH 280 MM
Published
2016-09-16
Public version status
Update
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
18032568034059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803256803405918032568034059

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length280Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+039456719000info@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
true
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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