DOLPHIX

Basic Information

• Brand Name: DOLPHIX
• Primary DI: 08052990972302
• Version / Model: Pilon fractures kit
• Catalog Number: DF100020
• Company Name: CITIEFFE SRL
• Labeler DUNS: 431406875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 18ca1914-4ecf-47a2-a781-6765ec224504

Device Description

Temporary external fixation kit composed of: - Clamp with bone screw ø 6mm L160mm (2 pcs); - Clamps with transfixing bone screw ø5mm L220mm (1 pc); - Rod to rod clamp (2 pcs); - Rod ø12mm L200mm (1 pc); - Rod ø12mm L280mm (2 pcs); - Hand drill (1 pc). Bone screw material: titanium alloy Ti6Al4V ELI (ASTM F136).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	888.3030	2
JDW	Pin, Fixation, Threaded	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48012	External orthopaedic fixation system, single-use, sterile	An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08052990972302	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K163323	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry and clean environment and avoid damaging the packing. Room temperature.