HEAD FEMORAL 28mm +9

FDA UDI

Class II (US FDA UDI)

by Biopro, Inc.

Identity

Trade Name: HEAD FEMORAL 28mm +9 FDA UDI
Generic Name: Metal-on-polyethylene total hip prosthesis FDA UDI
Model / Reference: 18592 FDA UDI

Identifiers

Primary DI / UDI-DI: M209185920 FDA UDI
FDA Product Code: JDI FDA UDI
LPH FDA UDI
GMDN Term: Metal-on-polyethylene total hip prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metal-on-polyethylene total hip prosthesis

HEAD FEMORAL 28mm +9 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-on-polyethylene total hip prosthesis.

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Libertas — MAXX ORTHOPEDICS INC. · Class II
Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
"UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
Conformis Hip System — Conformis, Inc. · Class II
Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · 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

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Manufacturer

Manufacturer: Biopro, Inc.

Sources (1)

FDA UDI 569bfe7d-c7ef-4eff-9a9a-4344ff32ea39 32 fields · synced Jun 1, 2026