OrthoPediatrics PediFoot Deformity Correction System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: OrthoPediatrics PediFoot Deformity Correction System FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: 1.6mm K Wire, Smooth, 75mm FDA UDI
Model / Reference: 01-1007-1701 FDA UDI
Description: 1.6mm K Wire, Smooth, 75mm FDA UDI

Identifiers

Catalog Number: 01-1007-1701 FDA UDI
Primary DI / UDI-DI: 00841132159460 FDA UDI
510(k) Number: K190992 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic guidewire, 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

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic guidewire, single-use

The OrthoPediatrics PediFoot Deformity Correction System is a medical device designed to guide the insertion of orthopaedic implants during surgical procedures. It features a thin, non-implantable rod made of metal, available in various sizes and designs, and is suitable for correction of deformities.

Similar devices

Also classified as Orthopaedic guidewire, single-use.

2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I
Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Headless Screw System Instruments — Tyber Medical · Class I
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM — Orthopediatrics Canada ULC · Class I
Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I

Cleared under the same submission

K190992 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI 8b5f2521-906a-4906-8c8f-576312bc50cb 36 fields · synced Jul 9, 2026