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Primo™ Acetabular System 881906168L

by b-ONE Ortho Corp.

Primo™ Acetabular System 881906168L is a Class II device made by b-ONE Ortho Corp., listed in FDA GUDID since 11 Feb 2026 (UDI-DI 00843575120175), 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 Number00843575120175 UDI-DI Date11 Feb 2026ListedStatusListed 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  • Withdrawn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
Primo™ Acetabular System
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
881906168L
Primary DI / UDI-DI
00843575120175
FDA product code
LZO, HWC, MEH
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class II
Regulation number
888.3353, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from b-ONE Ortho Corp.

See all devices from b-ONE Ortho Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)