Pediatric Nailing Platform | Tibia

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Pediatric Nailing Platform | Tibia FDA UDI
Generic Name: Orthopaedic x-ray ruler FDA UDI
Device Name: Canal Sizer FDA UDI
Model / Reference: 01-1510-0030 FDA UDI
Description: Canal Sizer FDA UDI

Identifiers

Catalog Number: 01-1510-0030 FDA UDI
Primary DI / UDI-DI: 00840194429054 FDA UDI
FDA Product Code: FTY FDA UDI
GMDN Term: Orthopaedic x-ray ruler 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: Orthopaedic x-ray ruler

Pediatric Nailing Platform | Tibia by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic x-ray ruler.

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RADIOGRAPHIC RULER, ANTEGRADE/RETROGRADE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MULTILOC — Synthes · Class II
COOLIEF* SINERGY* Epsilon* Ruler — Avanos Medical, Inc. · Class I
X-Ray Ruler — I.T.S. GmbH · Class I
PRECICE® Intramedullary Limb Lengthening System Instrument — NuVasive Specialized Orthopedics, Inc. · 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 7cf93e5e-adf1-4a8c-96b1-9a944f449f77 34 fields · synced Jun 8, 2026