Volition Plating System OS740426-NS

GUDID 05055662967593

CANNULATED DRILL BIT, Ø2.6MM FOR 3.5 SCREWS

ORTHO SOLUTIONS HOLDINGS LIMITED

Fluted surgical drill bit, single-use

• Primary Device ID: 05055662967593
• NIH Device Record Key: caa0bfba-0b10-4f37-81d7-44622d429636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volition Plating System
• Version Model Number: OS740426-NS
• Catalog Number: OS740426-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: 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 2.6 Millimeter
• Outer Diameter: 2.6 Millimeter
• Outer Diameter: 2.6 Millimeter
• Outer Diameter: 2.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662967593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163489

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[05055662967593]

Moist Heat or Steam Sterilization

[05055662967593]

Moist Heat or Steam Sterilization

[05055662967593]

Moist Heat or Steam Sterilization

[05055662967593]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [Volition Plating System]

• 05055662967814: FENESTRATOR, Ø1.8MM
• 05055662967807: VOLITION 3.5MM CANNULATED SCREW CADDY
• 05055662967784: VOLITION MTPJ PLATE CADDY
• 05055662967777: MTPJ GUIDE INSERT FOR 1.4MM GUIDE WIRE
• 05055662967760: MTPJ STANDARD PLATE GUIDE, RIGHT
• 05055662967753: MTPJ STANDARD PLATE GUIDE, LEFT
• 05055662967746: MTPJ INLINE PLATE GUIDE, BETA
• 05055662967739: MTPJ INLINE PLATE GUIDE, ALPHA
• 05055662967722: DRIVER FOR 3.5MM SCREW, CANNULATED T15 AO QC
• 05055662967715: RULE FOR 3.5MM SCREW
• 05055662967708: K-WIRE INSERT FOR 3.5MM SCREW
• 05055662967692: DRILL GUIDE FOR 3.5MM SCREW
• 05055662967593: CANNULATED DRILL BIT, Ø2.6MM FOR 3.5 SCREWS
• 05055662967586: GUIDE WIRE, Ø1.4MM
• 05055662967579: COUNTERSINK FOR 3.5MM HEADLESS SCREW CANNULATED AO QC
• 05055662967562: COUNTERSINK FOR 3.5MM HEADED SCREW CANNULATED AO QC
• 05055662967555: WASHER FOR 3.5MM HEADED CANN. SCREW
• 05055662967548: 3.5MM X 60MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967531: 3.5MM X 55MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967524: 3.5MM X 50MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967517: 3.5MM X 48MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967500: 3.5MM X 46MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967494: 3.5MM X 44MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967487: 3.5MM X 42MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967470: 3.5MM X 40MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967463: 3.5MM X 38MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967456: 3.5MM X 36MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967449: 3.5MM X 34MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967432: 3.5MM X 32MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967425: 3.5MM X 30MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967418: 3.5MM X 28MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967401: 3.5MM X 26MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967395: 3.5MM X 24MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967388: 3.5MM X 22MM HEADED CANNULATED SCREW PARTIALLY THREADED
• 05055662967371: 3.5MM X 60MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967364: 3.5MM X 55MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967357: 3.5MM X 50MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967340: 3.5MM X 48MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967333: 3.5MM X 46MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967326: 3.5MM X 44MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967319: 3.5MM X 42MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967302: 3.5MM X 40MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967296: 3.5MM X 38MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967289: 3.5MM X 36MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967272: 3.5MM X 34MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967265: 3.5MM X 32MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967258: 3.5MM X 30MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967241: 3.5MM X 28MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967234: 3.5MM X 26MM HEADLESS CANNULATED SCREW PARTIALLY THREADED
• 05055662967227: 3.5MM X 24MM HEADLESS CANNULATED SCREW PARTIALLY THREADED