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Dolphix

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
DOLPHIX FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Device Name
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). FDA UDI
Model / Reference
Pilon fractures kit FDA UDI
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). FDA UDI

Identifiers

Catalog Number
DF100020 FDA UDI
Primary DI / UDI-DI
08052990972302 FDA UDI
510(k) Number
K163323 FDA UDI
FDA Product Code
KTT FDA UDI
JDW FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: External orthopaedic fixation system, single-use, sterile

Dolphix by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use, sterile.

Cleared under the same submission

K163323 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Citieffe

Sources (1)

  • FDA UDI 18ca1914-4ecf-47a2-a781-6765ec224504 37 fields · synced May 30, 2026