Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Device Name: STEM, HIP FRACTUREURE10.5MM COLLARLESS 440 SERIES FDA UDI
Model / Reference: 440-00-105 FDA UDI
Description: STEM, HIP FRACTUREURE10.5MM COLLARLESS 440 SERIES FDA UDI

Identifiers

Primary DI / UDI-DI: 00888912085939 FDA UDI
510(k) Number: K973809 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 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: Press-fit femoral stem prosthesis

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

Similar devices

Also classified as Press-fit femoral stem prosthesis.

Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
Novation — Exactech, Inc. · Class II
Restoration — Howmedica Osteonics Corp. · Class II
Restoration — Howmedica Osteonics Corp. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Accolade — Howmedica Osteonics Corp. · Class II
BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

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 78a71e9c-0e4a-4d22-81dc-34c892723af1 34 fields · synced Jun 8, 2026