Locking Cannulated Blade System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Locking Cannulated Blade System FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: 100 degree LCB Child Cut Guide FDA UDI
Model / Reference: 01-1200-4084 FDA UDI
Description: 100 degree LCB Child Cut Guide FDA UDI

Identifiers

Catalog Number: 01-1200-4084 FDA UDI
Primary DI / UDI-DI: 00840194411165 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

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

Category: Osteotomy guide, reusable

Locking Cannulated Blade System by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI 605a36f5-b1cf-4606-9896-46ec0032b0fc 35 fields · synced Jun 8, 2026