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PedFlex Flexible Nailing System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
PedFlex Flexible Nailing System FDA UDI
Generic Name
Femur intramedullary nail FDA UDI
Device Name
ø3.5mm x 400mm Flexible IM Nail FDA UDI
Model / Reference
00-1000-035 FDA UDI
Description
ø3.5mm x 400mm Flexible IM Nail FDA UDI

Identifiers

Catalog Number
00-1000-035 FDA UDI
Primary DI / UDI-DI
00841132119389 FDA UDI
510(k) Number
K081097 FDA UDI
K201838 FDA UDI
K251362 FDA UDI
FDA Product Code
HTY FDA UDI
GMDN Term
Femur intramedullary nail FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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
MRI Safety
MR Conditional FDA UDI

Category: Femur intramedullary nail

PedFlex Flexible Nailing System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur intramedullary nail.

Cleared under the same submission

K081097 also covers:

K201838 also covers:

K251362 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 2bb62dd5-adf7-4d71-889a-40c690686687 36 fields · synced May 29, 2026