FDA.report

Fixion Nailing System

Primary DI
07290109330990
Brand
Fixion Nailing System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Dual Interlocking Tibial Nail
Catalog number
2713532
Device description
The interlocking intramedullary nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
07290109330990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109330990072901093309907290109330990

GMDN Terms

TermDefinition
Tibia nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length320Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-408-0120usa@carbo-fix.com

Regulatory Flags

DUNS number
649185170
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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