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Profemur

FDA UDI

Class III (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name
Profemur FDA UDI
Generic Name
Uncoated femoral stem prosthesis, modular FDA UDI
Device Name
PROFEMUR XTR Stem Size 4 FDA UDI
Model / Reference
PHA06008 FDA UDI
Description
PROFEMUR XTR Stem Size 4 FDA UDI

Identifiers

Catalog Number
PHA06008 FDA UDI
Primary DI / UDI-DI
M684PHA060081 FDA UDI
FDA Product Code
MRA FDA UDI
LZO FDA UDI
JDI FDA UDI
GMDN Term
Uncoated femoral stem prosthesis, modular FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3353 FDA UDI
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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 131 Millimeter FDA UDI

Category: Uncoated femoral stem prosthesis, modular

A comprehensive medical device directory entry for the Profemur XTR Stem, a uncoated femoral stem prosthesis designed to replace the proximal femoral neck in total hip arthroplasty (THA).

Similar devices

Also classified as Uncoated femoral stem prosthesis, modular.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroPort Orthopedics Inc.

Sources (1)

  • FDA UDI 703ffaf9-286d-4b65-8fe0-4d3ad8fee5b8 36 fields · synced Jun 27, 2026