AcuMatch

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: AcuMatch FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name: ACUMATCH REAMER SZ 2 FDA UDI
Model / Reference: 113-05-02 FDA UDI
Description: ACUMATCH REAMER SZ 2 FDA UDI

Identifiers

Catalog Number: 113-05-02 FDA UDI
Primary DI / UDI-DI: 10885862016997 FDA UDI
510(k) Number: K041906 FDA UDI
K051335 FDA UDI
K052787 FDA UDI
FDA Product Code: MEH FDA UDI
JDI FDA UDI
LWJ FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3350 FDA UDI
888.3360 FDA UDI
888.3358 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: Medullary canal orthopaedic reamer, rigid

AcuMatch by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medullary canal orthopaedic reamer, rigid.

POLARSTEM — Smith & Nephew, Inc. · Class II
Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
Panta® 2 — Ascension Orthopedics, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class I

Cleared under the same submission

K041906 also covers:

K051335 also covers:

K052787 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 12fd6c1b-1c7a-41cd-a8d2-daba42cb0be0 36 fields · synced May 30, 2026