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Primo™ Acetabular System 8819046072

by b-ONE Ortho Corp.

Primo™ Acetabular System 8819046072 is a Class I device made by b-ONE Ortho Corp., listed in FDA GUDID since 11 Feb 2026 (UDI-DI 00843575120267), 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 Number00843575120267 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  • Withdrawn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
Acetabular orthopaedic reamer
Model / Ref / Catalog
8819046072
Primary DI / UDI-DI
00843575120267
FDA product code
HTO
GMDN term
Acetabular orthopaedic reamer
Device class
Class I
Regulation number
888.4540
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
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)