PNP Tibia

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: PNP Tibia FDA UDI
Generic Name: Orthopaedic implant aiming arm FDA UDI
Device Name: Attachment Bolt FDA UDI
Model / Reference: 01-1510-0003-S FDA UDI
Description: Attachment Bolt FDA UDI

Identifiers

Catalog Number: 01-1510-0003-S FDA UDI
Primary DI / UDI-DI: 00840194472456 FDA UDI
510(k) Number: K250623 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Orthopaedic implant aiming arm FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic implant aiming arm

PNP Tibia by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant aiming arm.

ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
TARGETING ARM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
Jig — I.T.S. GmbH · Class I
ACUFEX — Smith & Nephew, Inc. · Class I
ENDO - KNEE — Smith & Nephew, Inc. · Class I
Proximal Humeral Fracture Plate System — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K250623 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI a051fd9f-77ce-4c83-8d2c-25a5831af08e 36 fields · synced May 30, 2026