BioPoly® Lesser Toe Hemiarthroplasty Implant 130-5113

GUDID 00850005618140

BioPoly® Lesser Toe Hemiarthroplasty Implant - 13mm Porous

Biopoly, LLC

Partial metatarsophalangeal joint prosthesis
Primary Device ID00850005618140
NIH Device Record Key9ec7e670-7513-4db1-b9c6-2c3b876ed440
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPoly® Lesser Toe Hemiarthroplasty Implant
Version Model Number130-5113
Catalog Number130-5113
Company DUNS023778928
Company NameBiopoly, 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

Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com
Phone260-999-6135
Emailinfo@biopolyortho.com

Device Dimensions

Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005618140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWDProsthesis, Toe, Hemi-, Phalangeal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [BioPoly® Lesser Toe Hemiarthroplasty Implant]

00850005618140BioPoly® Lesser Toe Hemiarthroplasty Implant - 13mm Porous
00850005618133BioPoly® Lesser Toe Hemiarthroplasty Implant - 12mm Porous
00850005618126BioPoly® Lesser Toe Hemiarthroplasty Implant - 11mm Porous
00850005618119BioPoly® Lesser Toe Hemiarthroplasty Implant - 10mm Porous
00850005618102BioPoly® Lesser Toe Hemiarthroplasty Implant - 9mm Porous

Trademark Results [BioPoly]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOPOLY
BIOPOLY
86204584 4620416 Live/Registered
BIOPOLY, LLC
2014-02-26
BIOPOLY
BIOPOLY
77932427 3852948 Live/Registered
BioPoly LLC
2010-02-10

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