BioPoly® Great Toe Hemiarthroplasty Implant 135-5116

GUDID 00850012119395

BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous

Biopoly, LLC

Partial metatarsophalangeal joint prosthesis
Primary Device ID00850012119395
NIH Device Record Keyaaa4a496-7aa3-4274-a38f-c925fcf35296
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPoly® Great Toe Hemiarthroplasty Implant
Version Model Number135-5116
Catalog Number135-5116
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
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 Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012119395 [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 Date2022-02-14
Device Publish Date2022-02-04

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

00850012119418BioPoly® Great Toe Hemiarthroplasty Implant - 20mm Porous
00850012119401BioPoly® Great Toe Hemiarthroplasty Implant - 18mm Porous
00850012119395BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous
00850012119388BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous
00850005618195BioPoly® Great Toe Hemiarthroplasty Implant - 22mm 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.