Orthex Half Pin

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Orthex Half Pin FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Half Pin, Orthex 6.0x150x55 Button, HA FDA UDI
Model / Reference: HP60-150-55B FDA UDI
Description: Half Pin, Orthex 6.0x150x55 Button, HA FDA UDI

Identifiers

Primary DI / UDI-DI: 00841132184097 FDA UDI
FDA Product Code: JDW FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Orthex Half Pin by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

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 80668757-bfa8-4e0b-bfc4-669aacdf6e29 34 fields · synced Jun 8, 2026