PROstep™ TBC

GUDID 00889797073110

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00889797073110
• NIH Device Record Key: e59303ab-8707-4d89-a9a8-75c7be543c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROstep™ TBC
• Version Model Number: 97700001
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797073110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183620

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [PROstep™ TBC]

• 00889797073271: 97700017
• 00889797073264: 97700016
• 00889797073257: 97700015
• 00889797073240: 97700014
• 00889797073233: 97700013
• 00889797073226: 97700012
• 00889797073219: 97700011
• 00889797073202: 97700010
• 00889797073196: 97700009
• 00889797073172: 97700007
• 00889797073165: 97700006
• 00889797073158: 97700005
• 00889797073141: 97700004
• 00889797073134: 97700003
• 00889797073127: 97700002
• 00889797073110: 97700001
• 00889797073103: 97700000
• 00889797100113: Broach
• 00889797100106: Broach
• 00889797100090: Broach
• 00889797100083: Broach
• 00889797100076: Broach
• 00889797100069: Broach
• 00889797100052: Hex Driver
• 00889797100021: Steinmann Pin
• 00889797100014: Shelf Drill