PROstep MIS 57S05080

GUDID 00889797104050

Chamfer Screw

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 00889797104050
• NIH Device Record Key: 1046f582-14ec-4432-aff4-82a45f6bf9fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROstep MIS
• Version Model Number: 57S05080
• Catalog Number: 57S05080
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797104050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221645

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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [PROstep MIS]

• 00889797104050: Chamfer Screw
• 00889797104043: Chamfer Screw
• 00889797104012: Chamfer Screw
• 00889797103992: Chamfer Screw
• 00889797103985: Chamfer Screw
• 00889797103978: Chamfer Screw
• 00889797103954: Chamfer Screw
• 00889797103916: Chamfer Screw
• 00889797103879: Chamfer Screw
• 00889797103862: Chamfer Screw
• 00889797103923: Chamfer Screw