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MOBIO™ Total Knee System

FDA UDI

Class I (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name
MOBIO™ Total Knee System FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
Headed Screw, 32mm FDA UDI
Model / Reference
8829016320 FDA UDI
Description
Headed Screw, 32mm FDA UDI

Identifiers

Catalog Number
8829016320 FDA UDI
Primary DI / UDI-DI
00843575104694 FDA UDI
FDA Product Code
HWD FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant/instrument assembling device

MOBIO™ Total Knee System by b-ONE Ortho Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
b-ONE Ortho Corp.

Sources (1)

  • FDA UDI e7c32484-8821-438e-90e7-0932379f3e57 34 fields · synced Jun 1, 2026