ORTHO SOLUTIONS SUCCESSION AFN SYSTEM OS355044-S

GUDID 05055662970920

5MM X 44MM M/L CORTICAL SCREW

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 05055662970920
• NIH Device Record Key: 3c3fdc6e-0168-4f72-a0e6-954d1f72a9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS SUCCESSION AFN SYSTEM
• Version Model Number: OS355044-S
• Catalog Number: OS355044-S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401621874378
• Email: regulatory@orthosol.com
• Phone: +4401621874378
• Email: regulatory@orthosol.com
• Phone: +4401621874378
• Email: regulatory@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662970920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250622

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [ORTHO SOLUTIONS SUCCESSION AFN SYSTEM]

• 05055662970784: SUCCESSION NAIL ASSEMBLY 12MM X 220MM
• 05055662970777: SUCCESSION NAIL ASSEMBLY 12MM X 190MM
• 05055662970739: SUCCESSION NAIL ASSEMBLY 11MM X 250MM
• 05055662970722: SUCCESSION NAIL ASSEMBLY 11MM X 220MM
• 05055662970715: SUCCESSION NAIL ASSEMBLY 11MM X 190MM
• 05055662970708: SUCCESSION NAIL ASSEMBLY 10MM X 250MM
• 05055662970692: SUCCESSION NAIL ASSEMBLY 10MM X 220MM
• 05055662971064: SUCCESSION 8.0MM PRIMARY REAMER
• 05055662971019: 6MM X 110MM P/A CORTICAL SCREW
• 05055662971002: 6MM X 105MM P/A CORTICAL SCREW
• 05055662970999: 6MM X 100MM P/A CORTICAL SCREW
• 05055662970982: 6MM X 95MM P/A CORTICAL SCREW
• 05055662970975: 6MM X 90MM P/A CORTICAL SCREW
• 05055662970968: 6MM X 85MM P/A CORTICAL SCREW
• 05055662970951: 5MM X 50MM M/L CORTICAL SCREW
• 05055662970944: 5MM X 48MM M/L CORTICAL SCREW
• 05055662970937: 5MM X 46MM M/L CORTICAL SCREW
• 05055662970920: 5MM X 44MM M/L CORTICAL SCREW
• 05055662970913: 5MM X 42MM M/L CORTICAL SCREW
• 05055662970906: 5MM X 40MM M/L CORTICAL SCREW
• 05055662970883: 5MM X 36MM M/L CORTICAL SCREW
• 05055662970876: 5MM X 34MM M/L CORTICAL SCREW
• 05055662970869: 5MM X 32MM M/L CORTICAL SCREW
• 05055662970852: 5MM X 30MM M/L CORTICAL SCREW
• 05055662970845: 5MM X 28MM M/L CORTICAL SCREW
• 05055662970838: 5MM X 26MM M/L CORTICAL SCREW
• 05055662970821: 5MM X 24MM M/L CORTICAL SCREW
• 05055662970814: 5MM X 22MM M/L CORTICAL SCREW
• 05055662970791: SUCCESSION NAIL ASSEMBLY 12MM X 250MM
• 05055662970760: SUCCESSION END CAP 12.5MM X 10MM
• 05055662970753: SUCCESSION END CAP 12.5MM X 5MM
• 05055662970746: SUCCESSION END CAP LOCKING
• 05055662970685: SUCCESSION NAIL ASSEMBLY 10MM X 190MM
• 05055662970647: SUCCESSION 3.2MM DIA STARTER K-WIRE
• 05055662970593: SUCCESSION 6MM DRILL GUIDE
• 05055662970500: SUCCESSION STAGE 2 DRIVER
• 05055662970494: SUCCESSION STAGE 1 DRIVER
• 05055662970470: SUCCESSION RETAINING SCREW DRIVER
• 05055662970463: SUCCESSION 13.5MM SECONDARY REAMER