OMNI Knee

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: OMNI Knee FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: Congruent Tibial Insert, Size 5 x 16mm FDA UDI
Model / Reference: KC-35056 FDA UDI
Description: Congruent Tibial Insert, Size 5 x 16mm FDA UDI

Identifiers

Catalog Number: KC-35056 FDA UDI
Primary DI / UDI-DI: 00841690101390 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Tibial insert

OMNI Knee by OMNIlife science, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

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: OMNIlife science, Inc.

Sources (1)

FDA UDI 9c7ccad9-64c1-4eb7-b8ae-302d84976cc8 35 fields · synced Jun 9, 2026