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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180249

OmniPore DUROMAX Surgical Implants · Matrix Surgical Holdings, LLC/Matrix Surgical USA · decided 2018-10-11 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OmniPore Surgical Implant OP9560MATRIX SURGICAL HOLDINGS, LLCJEY00852578008120
OmniPore Surgical Implant OP9550MATRIX SURGICAL HOLDINGS, LLCJEY00852578008106
OmniPore Surgical Implant OP9551MATRIX SURGICAL HOLDINGS, LLCJEY00852578008113
OmniPore Surgical Implant OP9561MATRIX SURGICAL HOLDINGS, LLCJEY00852578008137
OmniPore Surgical Implant OP9662MATRIX SURGICAL HOLDINGS, LLCJEY00852578008144