RTS Flexible 1st MPJ Implant w/Grommets

GUDID 00817906020021

Flexible Great Toe Implant

IN2BONES USA, LLC

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 00817906020021
• NIH Device Record Key: e8d5259c-ccff-4d13-9cba-a72962fd2e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTS Flexible 1st MPJ Implant w/Grommets
• Version Model Number: M30 SE030
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906020021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153609

FDA Product Code

• KWH: Prosthesis, Toe, Constrained, Polymer

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: 2016-11-05

On-Brand Devices [RTS Flexible 1st MPJ Implant w/Grommets]

• 00817906020038: Flexible Great Toe Implant
• 00817906020021: Flexible Great Toe Implant
• 00817906020014: Flexible Great Toe Implant
• 00817906020007: Flexible Great Toe Implant