RTS Flexible 1st MPJ Implant w/Grommets

GUDID 00817906020038

Flexible Great Toe Implant

IN2BONES USA, LLC

Total metatarsophalangeal joint prosthesis, one-piece
Primary Device ID00817906020038
NIH Device Record Key5a4a3625-8b45-401b-801a-bbc19e09fa25
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTS Flexible 1st MPJ Implant w/Grommets
Version Model NumberM30 SE040
Company DUNS079700711
Company NameIN2BONES USA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100817906020038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWHProsthesis, Toe, Constrained, Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-05

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

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

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