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Acumatch A Series

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Acumatch A Series FDA UDI
Generic Name
Acetabular shell FDA UDI
Model / Reference
120-01-58 FDA UDI

Identifiers

Catalog Number
120-01-58 FDA UDI
Primary DI / UDI-DI
10885862019769 FDA UDI
510(k) Number
K993082 FDA UDI
FDA Product Code
LPH FDA UDI
JDI FDA UDI
GMDN Term
Acetabular shell FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 58 Millimeter FDA UDI

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

Cleared under the same submission

K993082 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 3ec9814c-2788-492a-94a4-03cbdde74bfb 36 fields · synced Jun 8, 2026