TheRay Collared and Collarless Femoral Stem

FDA UDI

Class I (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name: TheRay Collared and Collarless Femoral Stem FDA UDI
Generic Name: Orthopaedic osteotome FDA UDI
Device Name: Box Osteotome, Collared Stem FDA UDI
Model / Reference: 12-80-0016 FDA UDI
Description: Box Osteotome, Collared Stem FDA UDI

Identifiers

Primary DI / UDI-DI: 00816127026997 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic osteotome 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

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome

TheRay Collared and Collarless Femoral Stem by Nextstep Arthropedix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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INSTRUMENT — Howmedica Osteonics Corp. · Class I
ORTHOMED — ORTHO-MED, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Nextstep Arthropedix

Sources (1)

FDA UDI 76a07f6a-63ea-4e82-96ef-e2707dc43da2 33 fields · synced May 31, 2026