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MOBIO™ Total Knee System 8821210400

by b-ONE Ortho Corp.

MOBIO™ Total Knee System 8821210400 is a Class II device made by b-ONE Ortho Corp., listed in FDA GUDID since 18 Nov 2022 (UDI-DI 00843575119759), 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 Number00843575119759 UDI-DI Date18 Nov 2022ListedStatusListed 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  • Withdrawn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
Uncoated knee tibia prosthesis, metallic
Model / Ref / Catalog
8821210400
Primary DI / UDI-DI
00843575119759
FDA product code
JWH
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, metallic

Other devices from b-ONE Ortho Corp.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)