Instrument

FDA UDI

Class I (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: RESTORATION MODULAR INST SYS BROACH TIP FDA UDI
Model / Reference: 6278-3-170 FDA UDI
Description: RESTORATION MODULAR INST SYS BROACH TIP FDA UDI

Identifiers

Catalog Number: 6278-3-170 FDA UDI
Primary DI / UDI-DI: 07613327220278 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic broach 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

Yes

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

Dimensions & Sizes

Size: Length — 127.0 Millimeter FDA UDI

Category: Orthopaedic broach

Instrument by Howmedica Osteonics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II
APEX Knee System — OMNIlife science, 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 8ec22da6-fb1d-4fe6-8e54-90023df7a61c 35 fields · synced May 30, 2026