Orthex External Fixation System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Orthex External Fixation System FDA UDI
Generic Name: Orthopaedic instrument surgical connector FDA UDI
Device Name: Angled Pin Connector Short FDA UDI
Model / Reference: 01-2200-0421 FDA UDI
Description: Angled Pin Connector Short FDA UDI

Identifiers

Catalog Number: 01-2200-0421 FDA UDI
Primary DI / UDI-DI: 00840194466998 FDA UDI
510(k) Number: K223786 FDA UDI
K243798 FDA UDI
FDA Product Code: KTT FDA UDI
GMDN Term: Orthopaedic instrument surgical connector 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic instrument surgical connector

Orthex External Fixation System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic instrument surgical connector.

Surgical Instrument — Jeil Medical Corporation · Class I
Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
QUANTUM — IN2BONES · Class I
KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Pilot Spinal System — Life Spine, Inc. · Class II
MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II

Cleared under the same submission

K223786 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI 476787b0-9a39-4e0f-8bda-c9ef988a5575 35 fields · synced May 30, 2026