Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Coated hip femur prosthesis, modular FDA UDI
Device Name: STEM, HIP,FH 480 SERIES SIZE10.5 PC FDA UDI
Model / Reference: 480-01-105 FDA UDI
Description: STEM, HIP,FH 480 SERIES SIZE10.5 PC FDA UDI

Identifiers

Primary DI / UDI-DI: 00888912086486 FDA UDI
510(k) Number: K991226 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
GMDN Term: Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
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: Coated hip femur prosthesis, modular

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

Similar devices

Also classified as Coated hip femur prosthesis, modular.

LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
ABG — Howmedica Osteonics Corp. · Class II
Z1™ Hip System — Zimmer, Inc. · Class II
VerSys® — Zimmer, Inc. · Class II
CATALYSTEM — Smith & Nephew, Inc. · Class II
Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Excia® L — AESCULAP, INC. · Class II
SYNERGY — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K991226 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: Encore Medical, L.p.

Sources (1)

FDA UDI 5abf8f50-02a9-4470-8e02-34dee0bd1a38 34 fields · synced May 31, 2026