Primo™ Acetabular System 8819046070

GUDID 00843575120243

ACETABULAR REAMER, 70MM

B-ONE ORTHO, CORP.

Acetabular orthopaedic reamer

• Primary Device ID: 00843575120243
• NIH Device Record Key: 092cd44d-0520-4563-86fc-8f25fa792d3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primo™ Acetabular System
• Version Model Number: 8819046070
• Catalog Number: 8819046070
• Company DUNS: 081315444
• Company Name: B-ONE ORTHO, CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843575120243 [Primary]

FDA Product Code

• HTO: Reamer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

[00843575120243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

On-Brand Devices [Primo™ Acetabular System]

• 00843575126641: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 72mm Outer Diameter; Size L Line
• 00843575126634: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 70mm Outer Diameter; Size L Line
• 00843575126627: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 68mm Outer Diameter; Size L Line
• 00843575126610: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 66mm Outer Diameter; Size L Line
• 00843575126603: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 64mm Outer Diameter; Size L Line
• 00843575126597: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 62mm Outer Diameter; Size L Line
• 00843575126580: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 62mm Outer Diameter; Size K Line
• 00843575126573: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 60mm Outer Diameter; Size K Line
• 00843575126566: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 60mm Outer Diameter; Size J Line
• 00843575126559: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 58mm Outer Diameter; Size J Line
• 00843575126542: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 58mm Outer Diameter; Size I Line
• 00843575126535: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 56mm Outer Diameter; Size I Line
• 00843575126528: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 56mm Outer Diameter; Size H Line
• 00843575126511: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 54mm Outer Diameter; Size H Line
• 00843575126504: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 54mm Outer Diameter; Size G Line
• 00843575126498: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 52mm Outer Diameter; Size G Line
• 00843575126481: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 52mm Outer Diameter; Size F Line
• 00843575126474: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 50mm Outer Diameter; Size F Line
• 00843575126467: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 50mm Outer Diameter; Size E Line
• 00843575126450: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 48mm Outer Diameter; Size E Line
• 00843575126443: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 48mm Outer Diameter; Size D Line
• 00843575126436: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 46mm Outer Diameter; Size D Line
• 00843575126429: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 46mm Outer Diameter; Size C Line
• 00843575126412: Cementless Acetabular Shell; Cluster Hole; Porous Plasma Spray; 44mm Outer Diameter; Size C Line
• 00843575124432: PPS Shell Trials Tray
• 00843575124425: Acetabular Reamers Tray
• 00843575120274: ACETABULAR REAMER, 73MM
• 00843575120267: ACETABULAR REAMER, 72MM
• 00843575120250: ACETABULAR REAMER, 71MM
• 00843575120243: ACETABULAR REAMER, 70MM
• 00843575120236: ACETABULAR REAMER, 69MM
• 00843575120229: ACETABULAR REAMER, 68MM
• 00843575120212: ACETABULAR REAMER, 67MM
• 00843575120205: ACETABULAR REAMER, 66MM
• 00843575120199: Shell Trial, 72MM OUTER DIAMETER x LINER SIZE L
• 00843575120182: Shell Trial, 70MM OUTER DIAMETER x LINER SIZE L
• 00843575120175: Shell Trial, 68MM OUTER DIAMETER x LINER SIZE L
• 00843575120168: Shell Trial, 66MM OUTER DIAMETER x LINER SIZE L
• 00843575116079: Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 72mm Outer Diameter,
• 00843575116062: Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 70mm Outer Diameter,
• 00843575116055: Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 68mm Outer Diameter,