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Orthex External Fixation System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Orthex External Fixation System FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
Orthex, Drill 4.8x285mm Solid FDA UDI
Model / Reference
Z402-285-48 FDA UDI
Description
Orthex, Drill 4.8x285mm Solid FDA UDI

Identifiers

Catalog Number
Z402-285-48 FDA UDI
Primary DI / UDI-DI
00840194428170 FDA UDI
FDA Product Code
GFG FDA UDI
GMDN Term
Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

Yes

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: Fluted surgical drill bit, single-use

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

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI c2e6111e-9976-4bfa-8da6-fa42b978f72c 34 fields · synced May 31, 2026