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Orthex

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Orthex FDA UDI
Generic Name
External orthopaedic fixation system noninvasive component, single-use FDA UDI
Device Name
Titanium Lock Nut, M4 FDA UDI
Model / Reference
611-04N FDA UDI
Description
Titanium Lock Nut, M4 FDA UDI

Identifiers

Catalog Number
611-04N FDA UDI
Primary DI / UDI-DI
00840194418072 FDA UDI
510(k) Number
K151881 FDA UDI
K223786 FDA UDI
K243798 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system noninvasive component, single-use 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

No

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

No

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

Category: External orthopaedic fixation system noninvasive component, single-use

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

Similar devices

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

Cleared under the same submission

K151881 also covers:

K223786 also covers:

K243798 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 4e183119-9e56-4c0b-a376-c16f26fece66 36 fields · synced Jun 8, 2026