FDA.report

BIOPOLY, LLC

Matched from indexed company URL: Biopoly, LLC

FDA Registration(s)

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

Registered Device Listings

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
14247111198423201969-12-31
14247111198423201969-12-31
14247111198423201969-12-31
14247111198423201969-12-31

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KWD22022-11-22
KWI12024-03-13

PMN

GUDID