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

Clearance record K222380

TriVerse Total Knee Replacement System · Signature Orthopaedics Pty, Ltd. · decided 2022-10-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TriVerse AS Tibia Insert Trial, 71x11122-22-6711SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215132354
V2 TriVerse Femoral Cutting Block122-22-4375SIGNATURE ORTHOPAEDICS PTY LTDMDM09348215128357
TriVerse Meniscal Insert PS+121-27-8071SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215107888
TriVerse Meniscal Insert CR121-27-4715SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215103712
TriVerse Meniscal Insert AS02-032-51-7120SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215102203
TriVerse Meniscal Insert AS02-032-51-6716SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215102104
TriVerse Meniscal Insert AS02-032-51-7914SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215101701
TriVerse Modular I-Beam121-27-0020SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215101091
TriVerse Modular Tray Trial122-22-3079SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215097691
TriVerse Asymmetric Patella Trial122-22-3162SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215097608
Triverse Tibia Insert Trial Combo, 63-67x14122-22-8374SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215128548
TriVerse Meniscal Insert PS+121-27-8459SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215108021
TriVerse Meniscal Insert PS+121-27-8479SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215107956
TriVerse Meniscal Insert PS+02-032-44-7124SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215104979
TriVerse Meniscal Insert CR02-032-47-7113SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215103682
TriVerse Meniscal Insert CR02-032-47-7112SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215103668
TriVerse Meniscal Insert AS02-032-51-5911SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215101886
TriVerse Meniscal Insert AS121-27-6715SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215101473
TriVerse Modular Tray121-27-0267SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215100919
TriVerse Tibial Insert Trial02-039-47-5910SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215109622
TriVerse Meniscal Insert PS+121-27-8713SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215107574
TriVerse Meniscal Insert CR02-032-47-7116SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215104221
TriVerse Femoral Component CR121-27-7055SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215100377
TriVerse Meniscal Insert PS+02-032-44-5924SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215107475
TriVerse Meniscal Insert PS+02-032-44-6320SIGNATURE ORTHOPAEDICS PTY LTDJWH OIY09348215104900