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External Fixator Self-drilling self-tapping pin 5x110

FDA UDI

Class II (US FDA UDI)

by Gexfix Sa

Identity

Trade Name
External Fixator Self-drilling self-tapping pin 5x110 FDA UDI
Generic Name
Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name
Non-bioabsorbable orthopaedic bone pin intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones 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, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use. FDA UDI
Model / Reference
2020-1035 FDA UDI
Description
Non-bioabsorbable orthopaedic bone pin intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones 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, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use. FDA UDI

Identifiers

Primary DI / UDI-DI
07640136270415 FDA UDI
510(k) Number
K052605 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

External Fixator Self-drilling self-tapping pin 5x110 by Gexfix Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Cleared under the same submission

K052605 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gexfix Sa

Sources (1)

  • FDA UDI a8cb214d-4a63-4a9e-af9e-57d0c2f29eff 34 fields · synced May 30, 2026