← Back to catalogue

Acumatch P Series

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Acumatch P Series FDA UDI
Generic Name
Press-fit femoral stem prosthesis FDA UDI
Model / Reference
118-01-00 FDA UDI

Identifiers

Catalog Number
118-01-00 FDA UDI
Primary DI / UDI-DI
10885862018861 FDA UDI
510(k) Number
K041906 FDA UDI
FDA Product Code
MEH FDA UDI
LZO FDA UDI
LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
GMDN Term
Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3360 FDA UDI
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
Length — 130 Millimeter FDA UDI

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

Cleared under the same submission

K041906 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 49261edd-d7a5-424f-87a1-0f8b29de0e03 36 fields · synced Jun 1, 2026