P.f.c.

FDA UDI

Class II (US FDA UDI)

by Depuy International Ltd

Identity

Trade Name: P.F.C. FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: P.F.C. TOTAL HIP SYSTEM ACETABULAR LINER 28mm 10 DEGREES 54-58mm FDA UDI
Model / Reference: 85-7724 FDA UDI
Description: P.F.C. TOTAL HIP SYSTEM ACETABULAR LINER 28mm 10 DEGREES 54-58mm FDA UDI

Identifiers

Catalog Number: 857724 FDA UDI
Primary DI / UDI-DI: 10603295215202 FDA UDI
510(k) Number: K873585 FDA UDI
K902137 FDA UDI
K930712 FDA UDI
K931189 FDA UDI
FDA Product Code: JDI FDA UDI
LZO FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3353 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: Non-constrained polyethylene acetabular liner

P.f.c. by Depuy International Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
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

K873585 also covers:

K902137 also covers:

K930712 also covers:

K931189 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 International Ltd

Sources (1)

FDA UDI 422e6778-aa1c-4791-99c7-1799cf298072 36 fields · synced Jun 8, 2026