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MOBIO™ Total Knee System 8829913300

by b-ONE Ortho Corp.

MOBIO™ Total Knee System 8829913300 is a Class I device made by b-ONE Ortho Corp., listed in FDA GUDID since 24 May 2019 (UDI-DI 00843575106162), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843575106162 UDI-DI Date24 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
MOBIO™ Total Knee System
Generic name
Surgical instrument/implant rack
Model / Ref / Catalog
8829913300
Primary DI / UDI-DI
00843575106162
FDA product code
LXH
GMDN term
Surgical instrument/implant rack
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument/implant rack

Similar devices

Also classified as Surgical instrument/implant rack.

Other devices from b-ONE Ortho Corp.

See all devices from b-ONE Ortho Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)