Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Instrument FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: Insignia Hip Stem Broach FDA UDI
Model / Reference: 8000-7701 FDA UDI
Description: Insignia Hip Stem Broach FDA UDI

Identifiers

Catalog Number: 8000-7701 FDA UDI
Primary DI / UDI-DI: 07613327519990 FDA UDI
510(k) Number: K211703 FDA UDI
FDA Product Code: KWZ FDA UDI
KWL FDA UDI
KWY FDA UDI
LWJ FDA UDI
LPH FDA UDI
MEH FDA UDI
LZO FDA UDI
JDI FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
888.3360 FDA UDI
888.3390 FDA UDI
888.3358 FDA UDI
888.3353 FDA UDI
888.3350 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 broach

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

Similar devices

Also classified as Orthopaedic broach.

EcoFit® broach for short stem 133° — implantcast GmbH · Class I
PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
Equinoxe — Exactech, Inc. · Class II
Anthology — Smith & Nephew, Inc. · Class I
Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II
APEX Knee System — OMNIlife science, Inc. · Class I

Cleared under the same submission

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

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 7af54707-36e3-43cf-88f5-3a8a00e99a76 36 fields · synced May 31, 2026