FDA-Device2022-03-09Class II
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
BioPro, Inc.
Hazard
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Sold states
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Manufactured in
2929 Lapeer Rd, Port Huron, MI, United States
Products
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0688-2022Don't want to check this manually?
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