Onvoy

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: ONVOY FDA UDI
Generic Name: Polyethylene acetabulum prosthesis FDA UDI
Device Name: ONVOY Acetabular EXp Liner, Hooded, 32mm ID, 58-60 OD FDA UDI
Model / Reference: 4235.4258S FDA UDI
Description: ONVOY Acetabular EXp Liner, Hooded, 32mm ID, 58-60 OD FDA UDI

Identifiers

Primary DI / UDI-DI: 00193982464981 FDA UDI
510(k) Number: K213842 FDA UDI
FDA Product Code: LPH FDA UDI
OQG FDA UDI
MBL FDA UDI
GMDN Term: Polyethylene acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 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

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

Category: Polyethylene acetabulum prosthesis

Onvoy by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene acetabulum prosthesis.

ZCA® — Zimmer, Inc. · Class II
Acetabular Insert — Howmedica Osteonics Corp. · Class II
Cenator Total Hip System — CORIN LTD · Class II
Exeter — Howmedica Osteonics Corp. · Class II
Exeter — Howmedica Osteonics Corp. · Class II
ZCA® — Zimmer, Inc. · Class II
REFLECTION — Smith & Nephew, Inc. · Class II
ZCA® — Zimmer, Inc. · Class II

Cleared under the same submission

K213842 also covers:

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: Globus Medical, Inc.

Sources (1)

FDA UDI 3078da92-bce7-4474-88a0-67b0526cc82f 34 fields · synced May 30, 2026