ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS OS361009

GUDID 05055662929294

MEMO STAPLE UNIVERSAL SPREADER

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 05055662929294
• NIH Device Record Key: f0ed6553-4832-47c4-aaf0-1fb11932cb95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
• Version Model Number: OS361009
• Catalog Number: OS361009
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• 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: false
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662929294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111678

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

[05055662929294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-05-16

On-Brand Devices [ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS]

• 05055662929355: EFS DRILL GUIDE 2.4MM/3.0MM SCREW
• 05055662929348: EFS DRILL GUIDE 1.2MM/2.0MM SCREW
• 05055662929317: COMPRESSION STAPLE DRILL GUIDE 2.7MM
• 05055662929294: MEMO STAPLE UNIVERSAL SPREADER
• 05055662929287: MEMO STAPLE 20MM & 25MM & 16MM EXPANDER
• 05055662929270: MEMO STAPLE 10MM & 12MM EXPANDER
• 05055662928921: FOS DRILL GUIDE
• 05055662923780: FPS 2.7MM DRILL GUIDE SHORT