TOE POROUS COATED MEDIUM SMALL 18.5mm

GUDID M209170340

BIOPRO, INC.

Partial metatarsophalangeal joint prosthesis
Primary Device IDM209170340
NIH Device Record Keyfbb20b4d-8e52-4033-8afd-601a11822a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOE POROUS COATED MEDIUM SMALL 18.5mm
Version Model Number17034
Company DUNS618749857
Company NameBIOPRO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM209170340 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-21
Device Publish Date2015-09-16

Devices Manufactured by BIOPRO, INC.

M209177990 - THUMB MOD HEAD TITANIUM 13MM+22024-07-08
M209178000 - THUMB MOD HEAD TITANIIUM 12MM2024-07-08
M209178010 - THUMB MOD HEAD TITANIUM 12MM+22024-07-08
M209178060 - THUMB MOD HEAD TITANIUM 14MM2024-07-08
M209178070 - THUMB MOD HEAD TITANIUM 14MM+22024-07-08
M209178080 - THUMB MOD HEAD TITANIUM 15MM2024-07-08
M209178090 - THUMB MOD HEAD TITANIUM 15MM+22024-07-08
M209177980 - THUMB MOD HEAD TITANIUM 13MM2024-06-07

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