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Primo™ Acetabular System 881312681L

by b-ONE Ortho Corp.

Primo™ Acetabular System 881312681L is a Class II device made by b-ONE Ortho Corp., listed in FDA GUDID since 11 Feb 2026 (UDI-DI 00843575116055), 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 Number00843575116055 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  • Withdrawn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
Metallic acetabulum prosthesis
Model / Ref / Catalog
881312681L
Description
Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 68mm Outer Diameter, Size L Liner
Primary DI / UDI-DI
00843575116055
FDA product code
LZO, MEH
GMDN term
Metallic acetabulum prosthesis
Device class
Class II
Regulation number
888.3353
GUDID distribution status
In Commercial Distribution

Other devices from b-ONE Ortho Corp.

See all devices from b-ONE Ortho Corp. →

Properties

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