P.f.c.

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: P.F.C. FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: P.F.C. TIBIAL INSERT FIXED BEARING CURVED 5 17.5mm GVF FDA UDI
Model / Reference: 98-4190 FDA UDI
Description: P.F.C. TIBIAL INSERT FIXED BEARING CURVED 5 17.5mm GVF FDA UDI

Identifiers

Catalog Number: 984190 FDA UDI
Primary DI / UDI-DI: 10603295252511 FDA UDI
510(k) Number: K884796 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

Category: Tibial insert

P.f.c. by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K884796 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: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI dc10ad21-5e6b-44d7-84f2-7f4c2c4c11ec 36 fields · synced Jun 6, 2026