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PediNail Intramedullary Platform

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
PediNail Intramedullary Platform FDA UDI
Generic Name
Screw-extraction orthopaedic reamer, single-use FDA UDI
Device Name
14.0MM MODULAR REAMER HEAD FDA UDI
Model / Reference
01-1500-140 FDA UDI
Description
14.0MM MODULAR REAMER HEAD FDA UDI

Identifiers

Catalog Number
01-1500-140 FDA UDI
Primary DI / UDI-DI
00841132150115 FDA UDI
FDA Product Code
HTO FDA UDI
GMDN Term
Screw-extraction orthopaedic reamer, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Screw-extraction orthopaedic reamer, single-use

A surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft. The PediNail Intramedullary Platform uses a unique modular reamer head to remove thin layers of bone until the internal thread grips the screw for removal.

Similar devices

Also classified as Screw-extraction orthopaedic reamer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI b20b46ad-5752-410f-82cb-e669df8ead08 35 fields · synced Jul 28, 2026