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AcuMatch

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
AcuMatch FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Device Name
NECK IMPACTOR, M-SERIES FDA UDI
Model / Reference
151-00-03 FDA UDI
Description
NECK IMPACTOR, M-SERIES FDA UDI

Identifiers

Catalog Number
151-00-03 FDA UDI
Primary DI / UDI-DI
10885862028839 FDA UDI
510(k) Number
K010120 FDA UDI
K011081 FDA UDI
K032964 FDA UDI
K051858 FDA UDI
K993736 FDA UDI
FDA Product Code
LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
GMDN Term
Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
888.3358 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K010120 also covers:

K011081 also covers:

K032964 also covers:

K051858 also covers:

K993736 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 653f72bf-6f17-4d3f-b465-cff05fe4492d 36 fields · synced Jun 1, 2026