FDA.reportPublic FDA data

Ankle Compression Nailing System

Primary DI
18033509858536
Brand
Ankle Compression Nailing System
Company
ORTHOFIX SRL
Model
1
Catalog number
99-T774060
Device description
TITANIUM LOW PROFILE SCREW, D 5MM L 60MM
Published
2015-09-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDSNail, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033509858536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803350985853618033509858536

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-cap, sterileA small, sterile, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+039456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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