Novation

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Novation FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: BROACH, TAPERED, SIZE 10 FDA UDI
Model / Reference: 161-02-10 FDA UDI
Description: BROACH, TAPERED, SIZE 10 FDA UDI

Identifiers

Catalog Number: 161-02-10 FDA UDI
Primary DI / UDI-DI: 10885862033475 FDA UDI
510(k) Number: K042842 FDA UDI
K052787 FDA UDI
K063279 FDA UDI
K083392 FDA UDI
K102487 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
LWJ FDA UDI
JDI FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3360 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

Novation by Exactech, Inc. — 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
INSTRUMENT — Howmedica Osteonics Corp. · Class I
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

K042842 also covers:

K052787 also covers:

K063279 also covers:

K083392 also covers:

K102487 also covers:

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: Exactech, Inc.

Sources (1)

FDA UDI 2401d19b-7eee-4faa-8b08-3aff69c7255b 36 fields · synced May 30, 2026