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Pantheon PFR System

FDA UDI

Class II (US FDA UDI)

by Adler Ortho Spa

Identity

Trade Name
Pantheon PFR System FDA UDI
Generic Name
Revision uncoated femoral stem prosthesis FDA UDI
Device Name
Pantheon Proximal Body – Flat – L70mm (Medium) FDA UDI
Model / Reference
Proximal Body FDA UDI
Description
Pantheon Proximal Body – Flat – L70mm (Medium) FDA UDI

Identifiers

Catalog Number
0200225 FDA UDI
Primary DI / UDI-DI
08050880237531 FDA UDI
FDA Product Code
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
GMDN Term
Revision uncoated femoral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3358 FDA UDI
888.3350 FDA UDI
888.3353 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

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI

Category: Revision uncoated femoral stem prosthesis

Pantheon PFR System by Adler Ortho Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Revision uncoated femoral stem prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adler Ortho Spa

Sources (1)

  • FDA UDI c41d4455-3247-47ed-b54f-50de6fa916d8 35 fields · synced May 30, 2026