Acumatch M-Series

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Acumatch M-Series FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: Femoral Head Impactor FDA UDI
Model / Reference: SPI-003185 FDA UDI
Description: Femoral Head Impactor FDA UDI

Identifiers

Catalog Number: SPI-003185 FDA UDI
Primary DI / UDI-DI: 10885862629432 FDA UDI
510(k) Number: K032964 FDA UDI
K041906 FDA UDI
K050398 FDA UDI
K051682 FDA UDI
K060107 FDA UDI
K103012 FDA UDI
K173583 FDA UDI
FDA Product Code: MEH FDA UDI
LZO FDA UDI
JDI FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 implant impactor, reusable

Acumatch M-Series by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic implant impactor, reusable.

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Cleared under the same submission

K032964 also covers:

AcuMatch — Exactech, Inc.

K041906 also covers:

K050398 also covers:

K051682 also covers:

Novation — Exactech, Inc.

K060107 also covers:

K103012 also covers:

K173583 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 84ec0ce5-81d5-4966-8322-6bbbeba3e03a 35 fields · synced May 30, 2026