Implant and Instrument Set 7.0mm

GUDID 00850072364001

Bone Bolt System Implant and Instrument Set 7.0mm

ORTHO OUTCOMES, LLC

Orthopaedic bone bolt

• Primary Device ID: 00850072364001
• NIH Device Record Key: f748ca1d-3900-4b25-ae58-bd485503357f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant and Instrument Set 7.0mm
• Version Model Number: 104-0425
• Company DUNS: 133439875
• Company Name: ORTHO OUTCOMES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850072364001 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

[00850072364001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-29
• Device Publish Date: 2025-07-21

Devices Manufactured by ORTHO OUTCOMES, LLC

• 00850072364001 - Implant and Instrument Set 7.0mm: 2025-07-29Bone Bolt System Implant and Instrument Set 7.0mm
• 00850072364001 - Implant and Instrument Set 7.0mm: 2025-07-29 Bone Bolt System Implant and Instrument Set 7.0mm
• 00850072364018 - 660mm Length Guidewires for 7.0 System: 2025-07-29 Bone Bolt System - 660mm Length Guidewires for 7.0 System