Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: FLARED RIM SHELL, HIP, P2 COATED W/O SCREWHOLES, 42MM FDA UDI
Model / Reference: 430-96-042 FDA UDI
Description: FLARED RIM SHELL, HIP, P2 COATED W/O SCREWHOLES, 42MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00888912083638 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Acetabular shell 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: Acetabular shell

Djo Surgical by Encore Medical, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acetabular shell.

Klassic HD Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
POLARCUP — Smith & Nephew, Inc. · Class II
ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
InSitu Hip System — Nextstep Arthropedix · Class II
REFLECTION — Smith & Nephew, Inc. · Class II
Regenerex® Ringloc®+ Hip System — Biomet Orthopedics, Inc. · Class II
Logical G-Series Acetabular Shell — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Encore Medical, L.p.

Sources (1)

FDA UDI f8480a96-d1e9-4fbd-a1d7-449099b4fb68 33 fields · synced Jun 6, 2026