ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS OS315115

GUDID 05055662905489

8.0MM X 115MM TITANIUM CANN. CANCELLOUS SCREW 18MM THREAD

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 05055662905489
• NIH Device Record Key: 90e71d7d-b724-4722-aa98-9daa89dcd382
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
• Version Model Number: OS315115
• Catalog Number: OS315115
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662905489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110895

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-22

On-Brand Devices [ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS]

• 05055662947687: STEINMANN PIN 4.0MM X 150MM, TROCAR TIP (CALIBRATED)
• 05055662947632: 4.0MM CANNULATED SCREW CUP WASHER
• 05055662935325: MISS GRADUATED K-WIRE
• 05055662934793: 5.0MM CANN. SCREW PIN 2.0MM X 9 inches THREADED TIP
• 05055662934779: 5.0MM CANN. SCREW PIN 2.0MM X 9 inches BAYONET TIP
• 05055662934533: HEADLESS CANNULATED SCREW GUIDE PIN 0.035 inches X 6 inches
• 05055662934359: 6.5/8.0MM CANN. SCREW PIN 3.2MM X 300MM
• 05055662934311: 4.0MM CANN. SCREW PIN 1.4MM X 150MM
• 05055662934090: REAMING ROD 2.6MM X 900MM, OLIVE
• 05055662933918: 6.5/8.0MM CANN. SCREW PIN 3.2MM X 9 inches
• 05055662933895: 7.3MM CANN.SCREW GUIDE PIN 2.8MM X 300MM
• 05055662933871: 6.5MM CANN. SCREW GUIDE PIN 2.4MM X 230MM
• 05055662933833: 4.0MM CANN. SCREW PIN 1.6MM X 150MM
• 05055662933673: 4.0MM CANN. SCREW GUIDE PIN 1.25MM X 150MM
• 05055662928181: 5.0MM CANN. SCREW PARALLEL WIRE/3.8MM DRILL GUIDE
• 05055662928105: 4.0MM CANN. SCREW PARALLEL WIRE/2.9MM DRILL GUIDE
• 05055662928075: 6.5/8.0 SCREWDRIVER SHANK
• 05055662923193: K-WIRE TROCAR TIP 2.2MM X 310MM
• 05055662923155: K-WIRE TROCAR TIP 2.0MM X 200MM
• 05055662923018: K-WIRE TROCAR TIP 1.6MM X 125MM
• 05055662922998: K-WIRE TROCAR TIP 1.6MM X 150MM
• 05055662922974: K-WIRE TROCAR TIP 1.4MM X 150MM
• 05055662922950: K-WIRE 1.6MM X 150MM WITH DOUBLE THREADED TIP
• 05055662922899: K-WIRE TROCAR TIP 1.25MM X 150MM
• 05055662922813: K-WIRE TROCAR TIP 1.0MM X 70MM
• 05055662922752: K-WIRE 1.5MM X 75MM WITH THREADED TIP 30MM
• 05055662922677: K-WIRE TROCAR TIP 0.8MM X 80MM
• 05055662922578: K-WIRE FULLY THREADED 1.5MM X 100MM
• 05055662922486: K-WIRE DOUBLE TROCAR 2.0MM X 150MM
• 05055662922424: K-WIRE DOUBLE TROCAR 1.8MM x 150MM
• 05055662922349: K-WIRE DOUBLE TROCAR 1.6MM X 250MM
• 05055662922301: K-WIRE DOUBLE TROCAR 1.6MM X 200MM
• 05055662922264: K-WIRE DOUBLE TROCAR 1.6MM x 125MM
• 05055662922226: K-WIRE DOUBLE TROCAR 1.6MM x 100MM
• 05055662922202: K-WIRE DOUBLE TROCAR 1.4MM x 150MM
• 05055662922189: K-WIRE DOUBLE TROCAR 1.4MM x 100MM
• 05055662922127: K-WIRE DOUBLE TROCAR 1.2MM X 150MM
• 05055662922103: K-WIRE DOUBLE TROCAR 1.2MM x 100MM
• 05055662921984: K-WIRE DOUBLE TROCAR 1.1MM x 150MM
• 05055662921960: K-WIRE DOUBLE TROCAR 1.1MM x 125MM
• 05055662921922: K-WIRE DOUBLE TROCAR 1.1MM x 100MM
• 05055662921823: K-WIRE DOUBLE TROCAR 1.0MM X 100MM
• 05055662921649: K-WIRE TROCAR TIP 1.1MM X 150MM
• 05055662921540: K-WIRE DOUBLE TROCAR 1.2MM x 125MM
• 05055662921502: K-WIRE DOUBLE TROCAR 0.9MM X 100MM
• 05055662921403: RFS TITANIUM STRAIGHT WIRE 1.8MM X 370MM
• 05055662921373: RFS STRAIGHT WIRE 1.5MM X 300MM
• 05055662921298: RFS STRAIGHT WIRE 1.8MM X 370MM
• 05055662921267: CERCLAGE BONE WIRE 1.5MM X 400MM (17 GAUGE)
• 05055662921243: CERCLAGE BONE WIRE 1.2MM X 400MM (18 GAUGE)