Omnifit

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Omnifit FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: 10 Degree Series II Insert FDA UDI
Model / Reference: 2041C-2852 FDA UDI
Description: 10 Degree Series II Insert FDA UDI

Identifiers

Catalog Number: 2041C-2852 FDA UDI
Primary DI / UDI-DI: 07613327021660 FDA UDI
510(k) Number: K974685 FDA UDI
FDA Product Code: LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 28.0 Millimeter FDA UDI

Category: Non-constrained polyethylene acetabular liner

Omnifit by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

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PRIME — MicroPort Orthopedics Inc. · Class II
G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, INC. · 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 544f85b2-8b92-4021-8384-cc2970b67ee9 36 fields · synced May 30, 2026