Mpact Constrained Liner

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: Mpact Constrained Liner FDA UDI
Generic Name: Constrained polyethylene acetabular liner FDA UDI
Device Name: Constrained 10° PE liner Ø28/F FDA UDI
Model / Reference: 01.32.2848CL10A FDA UDI
Description: Constrained 10° PE liner Ø28/F FDA UDI

Identifiers

Primary DI / UDI-DI: 07630542722769 FDA UDI
510(k) Number: K241461 FDA UDI
FDA Product Code: KWZ FDA UDI
GMDN Term: Constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
Commercial Distribution: 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Constrained polyethylene acetabular liner

Mpact Constrained Liner by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Constrained polyethylene acetabular liner.

Omnifit — Howmedica Osteonics Corp. · Class II
Trilogy® — Zimmer, Inc. · Class II
Trident — Howmedica Osteonics Corp. · Class II
System 12 — Howmedica Osteonics Corp. · Class II
Trabecular Metal® Acetabular Revision System — Zimmer, Inc. · Class II
Omnifit — Howmedica Osteonics Corp. · Class II
G7® Freedom® Vivacit-E® — Zimmer, Inc. · Class II
System 12 — Howmedica Osteonics Corp. · Class II

Cleared under the same submission

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: Medacta International

Sources (1)

FDA UDI 663c387b-f082-4190-8ae0-97e242d11df0 34 fields · synced May 30, 2026