Mcs

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: MCS FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: 104-32-46 FDA UDI

Identifiers

Catalog Number: 104-32-46 FDA UDI
Primary DI / UDI-DI: 10885862013613 FDA UDI
510(k) Number: K051556 FDA UDI
FDA Product Code: JDI FDA UDI
LPH FDA UDI
LWJ FDA UDI
LZO FDA UDI
MEH FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3353 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 32 Millimeter FDA UDI

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

Cleared under the same submission

K051556 also covers:

Acumatch A Series — Exactech, Inc.
Novation — Exactech, Inc.

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

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Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 6dba8f12-2d1d-401d-8f5c-d7e31f9bfdd1 36 fields · synced May 31, 2026