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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
Orthex Pin Cube Sgl LB FDA UDI
Model / Reference
350-M6-01 FDA UDI
Description
Orthex Pin Cube Sgl LB FDA UDI

Identifiers

Catalog Number
350-M6-01 FDA UDI
Primary DI / UDI-DI
00841132141366 FDA UDI
510(k) Number
K151881 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

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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 8c3e609a-46c9-4abc-a3c8-60a7d80bacec 36 fields · synced Jun 1, 2026