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Acumatch L-Series

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Acumatch L-Series FDA UDI
Generic Name
Metallic femoral head prosthesis FDA UDI
Model / Reference
102-20-10 FDA UDI

Identifiers

Catalog Number
102-20-10 FDA UDI
Primary DI / UDI-DI
10885862011879 FDA UDI
510(k) Number
K010081 FDA UDI
FDA Product Code
KWY FDA UDI
GMDN Term
Metallic femoral head prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3390 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — +10 Millimeter FDA UDI

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

Cleared under the same submission

K010081 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 7bbe3d45-e970-4484-9a5c-40ab4a812cbd 36 fields · synced Jun 8, 2026