← Back to catalogue

3P Hip System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
3P Hip System FDA UDI
Generic Name
Femoral neck fixation plate/sleeve FDA UDI
Device Name
130° Adolescent Offset Wide Plate, 3-Hole, 14mm Offset FDA UDI
Model / Reference
00-3011-3343 FDA UDI
Description
130° Adolescent Offset Wide Plate, 3-Hole, 14mm Offset FDA UDI

Identifiers

Catalog Number
00-3011-3343 FDA UDI
Primary DI / UDI-DI
00840194481663 FDA UDI
510(k) Number
K243963 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Femoral neck fixation plate/sleeve 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

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
MRI Safety
MR Conditional FDA UDI

Category: Femoral neck fixation plate/sleeve

3P Hip System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral neck fixation plate/sleeve.

Cleared under the same submission

K243963 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 1b9836b9-7ad2-4a4f-9fa7-a4eba8c392a0 36 fields · synced May 30, 2026