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Osseointegration Prosthetic Limb

FDA UDI

Class I (US FDA UDI)

by Osseointegration International Pty Ltd

Identity

Trade Name
Osseointegration Prosthetic Limb FDA UDI
Generic Name
External lower-limb prosthesis structural/alignment component FDA UDI
Device Name
LLC Bushing FDA UDI
Model / Reference
0 Degree Bushing FDA UDI
Description
LLC Bushing FDA UDI

Identifiers

Catalog Number
OPL-LLC-B FDA UDI
Primary DI / UDI-DI
19356371001053 FDA UDI
FDA Product Code
IQO FDA UDI
GMDN Term
External lower-limb prosthesis structural/alignment component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: External lower-limb prosthesis structural/alignment component

Osseointegration Prosthetic Limb by Osseointegration International Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External lower-limb prosthesis structural/alignment component.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osseointegration International Pty Ltd

Sources (1)

  • FDA UDI c32fc419-0014-4a89-9ff0-c93850036d1a 34 fields · synced May 30, 2026