FDA 510(k) Applications Submitted by SWEDEN & MARTINA S.p.A.

FDA 510(k) Number Submission Date Device Name Applicant
K180365 02/12/2018 PRAMA White Implant Systems Sweden & Martina S.p.A.
K161989 07/19/2016 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A.
K162004 07/20/2016 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A.
K162028 07/22/2016 PREMIUM - SHELTA Prosthetic Components SWEDEN & MARTINA S.p.A.
K182084 08/02/2018 Sweden & Martina Surgical Tray (Model ZSHORTY-INT) Sweden & Martina S.p.A.
K222640 09/01/2022 Sweden & Martina Surgical Trays Sweden & Martina S.p.A.
K142242 08/13/2014 PREMIUM, SHELTA Implant Systems SWEDEN & MARTINA S.P.A.


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