FDA.reportPublic FDA data

BIOPOLY, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30081087893008108789BIOPOLY, LLC1N2026-01-017136 Gettysburg Pike Fort Wayne IN US 46804

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005618034BioPoly® Radial Head Implant - BioPoly® Radial Head Implant, 20 x 6(+0)mm260-999-6135info@biopolyortho.com
00850005618041BioPoly® Radial Head Implant - BioPoly® Radial Head Implant, 20 x 6(+3)mm260-999-6135info@biopolyortho.com
00850005618058BioPoly® Radial Head Implant - BioPoly® Radial Head Implant, 20 x 6(+6)mm260-999-6135info@biopolyortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1424711237606151K233592BioPoly Radial Head ImplantKWI2024-03-13
1424712037040536K222964BioPoly Lesser Toe Hemiarthroplasty ImplantKWD2022-11-22
1424711906160420K203634BioPoly Great Toe Hemiarthroplasty ImplantKWD2021-02-02
1424711119842320

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWD22022-11-22
KWI12024-03-13

PMN#

GUDID#