ORTHO SOLUTIONS ULTOS PLATING SYSTEM OS423019-NS

GUDID 05055662903157

COMPRESSION DISTRACTION DEVICE SMALL

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic surgical distractor, internal

• Primary Device ID: 05055662903157
• NIH Device Record Key: 5613e635-4b2c-4357-b716-d5335d9d0ab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS ULTOS PLATING SYSTEM
• Version Model Number: OS423019-NS
• Catalog Number: OS423019-NS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662903157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141784

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[05055662903157]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-15

On-Brand Devices [ORTHO SOLUTIONS ULTOS PLATING SYSTEM]

• 05055662948578: UltOS AXIAL HANDLE NARROW GRIP RATCHETING CANN. AO QC BLACK
• 05055662948523: UltOS 2.5MM HEX DRIVER CANNULATED AO QC
• 05055662948516: UltOS T8 TORX DRIVER SOLID AO QC
• 05055662948479: UltOS T8 TORX DRIVER
• 05055662947564: 3.5MM X 60MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947557: 3.5MM X 55MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947540: 3.5MM X 50MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947533: 3.5MM X 45MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947526: 3.5MM X 40MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947519: 3.5MM X 38MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947502: 3.5MM X 36MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947496: 3.5MM X 34MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947489: 3.5MM X 32MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947472: 3.5MM X 30MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947465: 3.5MM X 28MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947458: 3.5MM X 25MM CANNULATED SCREW SELF DRILL/TAP
• 05055662947441: UltOS 3.5MM NON-LOCKING SCREW 50MM
• 05055662947434: UltOS 3.5MM NON-LOCKING SCREW 45MM
• 05055662947427: UltOS 3.5MM NON-LOCKING SCREW 40MM
• 05055662947410: UltOS 3.5MM NON-LOCKING SCREW 35MM
• 05055662947403: UltOS 3.5MM NON-LOCKING SCREW 30MM
• 05055662947397: UltOS 3.5MM NON-LOCKING SCREW 28MM
• 05055662947380: UltOS 3.5MM NON-LOCKING SCREW 26MM
• 05055662947373: UltOS 3.5MM NON-LOCKING SCREW 24MM
• 05055662947366: UltOS 3.5MM NON-LOCKING SCREW 22MM
• 05055662947359: UltOS 3.5MM NON-LOCKING SCREW 20MM
• 05055662947342: UltOS 3.5MM NON-LOCKING SCREW 18MM
• 05055662947335: UltOS 3.5MM NON-LOCKING SCREW 16MM
• 05055662947328: UltOS 3.5MM NON-LOCKING SCREW 14MM
• 05055662947311: UltOS 3.5MM LOCKING SCREW 50MM
• 05055662947304: UltOS 3.5MM LOCKING SCREW 45MM
• 05055662947298: UltOS 3.5MM LOCKING SCREW 40MM
• 05055662947281: UltOS 3.5MM LOCKING SCREW 35MM
• 05055662947274: UltOS 3.5MM LOCKING SCREW 30MM
• 05055662947267: UltOS 3.5MM LOCKING SCREW 28MM
• 05055662947250: UltOS 3.5MM LOCKING SCREW 26MM
• 05055662947243: UltOS 3.5MM LOCKING SCREW 24MM
• 05055662947236: UltOS 3.5MM LOCKING SCREW 22MM
• 05055662947229: UltOS 3.5MM LOCKING SCREW 20MM
• 05055662947212: UltOS 3.5MM LOCKING SCREW 18MM
• 05055662947205: UltOS 3.5MM LOCKING SCREW 16MM
• 05055662947199: UltOS 3.5MM LOCKING SCREW 14MM
• 05055662947182: UltOS 3.5MM LOCKING SCREW 12MM
• 05055662947175: UltOS 3.5MM LOCKING SCREW 10MM
• 05055662947168: UltOS 2.7MM NON-LOCKING SCREW 30MM
• 05055662947151: UltOS 2.7MM NON-LOCKING SCREW 28MM
• 05055662947144: UltOS 2.7MM NON-LOCKING SCREW 26MM
• 05055662947137: UltOS 2.7MM NON-LOCKING SCREW 24MM
• 05055662947120: UltOS 2.7MM NON-LOCKING SCREW 22MM
• 05055662947113: UltOS 2.7MM NON-LOCKING SCREW 20MM