Volition™ Plating System OS731051R-NS

GUDID 05055662963489

TIBIA PLATE, MEDIAL, RIGHT

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 05055662963489
• NIH Device Record Key: 561c6811-7ca9-459d-b159-c9bc660dd0e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volition™ Plating System
• Version Model Number: OS731051R-NS
• Catalog Number: OS731051R-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: 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
• 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	05055662963489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202764

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

[05055662963489]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [Volition™ Plating System]

• 05055662966343: K-WIRE TROCAR TIP 2.0MM X 200MM
• 05055662964844: FLAT WASHER FOR 2.7-4.0MM NON-LOCKING SCREWS
• 05055662964769: NON-LOCKING SCREW, 4.0 X 60MM
• 05055662964752: NON-LOCKING SCREW, 4.0 X 55MM
• 05055662964745: NON-LOCKING SCREW, 4.0 X 50MM
• 05055662964738: NON-LOCKING SCREW, 4.0 X 48MM
• 05055662964721: NON-LOCKING SCREW, 4.0 X 46MM
• 05055662964714: NON-LOCKING SCREW, 4.0 X 44MM
• 05055662964707: NON-LOCKING SCREW, 4.0 X 42MM
• 05055662964691: NON-LOCKING SCREW, 4.0 X 40MM
• 05055662964684: NON-LOCKING SCREW, 4.0 X 38MM
• 05055662964677: NON-LOCKING SCREW, 4.0 X 36MM
• 05055662964660: NON-LOCKING SCREW, 4.0 X 34MM
• 05055662964653: NON-LOCKING SCREW, 4.0 X 32MM
• 05055662964646: NON-LOCKING SCREW, 4.0 X 30MM
• 05055662964639: NON-LOCKING SCREW, 4.0 X 28MM
• 05055662964622: NON-LOCKING SCREW, 4.0 X 26MM
• 05055662964615: NON-LOCKING SCREW, 4.0 X 24MM
• 05055662964608: NON-LOCKING SCREW, 4.0 X 22MM
• 05055662964592: NON-LOCKING SCREW, 4.0 X 20MM
• 05055662964585: NON-LOCKING SCREW, 4.0 X 18MM
• 05055662964578: NON-LOCKING SCREW, 4.0 X 16MM
• 05055662964561: NON-LOCKING SCREW, 4.0 X 14MM
• 05055662964554: NON-LOCKING SCREW, 4.0 X 12MM
• 05055662964547: NON-LOCKING SCREW, 4.0 X 10MM
• 05055662964530: LOCKING SCREW, 4.0 X 60MM
• 05055662964523: LOCKING SCREW, 4.0 X 55MM
• 05055662964516: LOCKING SCREW, 4.0 X 50MM
• 05055662964509: LOCKING SCREW, 4.0 X 48MM
• 05055662964493: LOCKING SCREW, 4.0 X 46MM
• 05055662964486: LOCKING SCREW, 4.0 X 44MM
• 05055662964479: LOCKING SCREW, 4.0 X 42MM
• 05055662964462: LOCKING SCREW, 4.0 X 40MM
• 05055662964455: LOCKING SCREW, 4.0 X 38MM
• 05055662964448: LOCKING SCREW, 4.0 X 36MM
• 05055662964431: LOCKING SCREW, 4.0 X 34MM
• 05055662964424: LOCKING SCREW, 4.0 X 32MM
• 05055662964417: LOCKING SCREW, 4.0 X 30MM
• 05055662964400: LOCKING SCREW, 4.0 X 28MM
• 05055662964394: LOCKING SCREW, 4.0 X 26MM
• 05055662964387: LOCKING SCREW, 4.0 X 24MM
• 05055662964370: LOCKING SCREW, 4.0 X 22MM
• 05055662964363: LOCKING SCREW, 4.0 X 20MM
• 05055662964356: LOCKING SCREW, 4.0 X 18MM
• 05055662964349: LOCKING SCREW, 4.0 X 16MM
• 05055662964332: LOCKING SCREW, 4.0 X 14MM
• 05055662964325: LOCKING SCREW, 4.0 X 12MM
• 05055662964318: LOCKING SCREW, 4.0 X 10MM
• 05055662964301: NON-LOCKING SCREW, 3.5 X 60MM
• 05055662964295: NON-LOCKING SCREW, 3.5 X 55MM