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

Clearance record K181530

World Total Knee System · Signature Orthopaedics Pty, Ltd. · decided 2018-10-24 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
World Knee PS All Poly Tibia121-20-6709SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215116408
World Knee System121-20-8400SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037574
World Knee CR All Poly Tibia121-20-6919SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215116330
World Knee CR All Poly Tibia121-20-6619SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215116309
World Knee System121-20-0403SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037796
World Knee System121-20-6510SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215036973
World Knee System121-20-6102SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215036270
World Knee Spherical Patella – Finned Peg121-20-8420SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215139179
World Knee CR All Poly Tibia121-20-6128SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215115999
World Knee System121-20-1611SIGNATURE ORTHOPAEDICS PTY LTDMBH09348215035778
World Knee Spherical Patella – Finned Peg Vit-E 121-20-8620ESIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215134334
World Knee System121-20-0613SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037901
World Knee System121-20-1912SIGNATURE ORTHOPAEDICS PTY LTDMBH09348215035891
World Knee Asymmetrical Patella – Finned Peg121-20-8230SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215139254
World Knee Spherical Patella – Finned Peg121-20-8020SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215139131
World Knee UC All Poly Tibia121-20-6438SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215116194
World Knee System121-20-6700SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215036690
World Knee Spherical Patella Vit-E 121-20-8000ESIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215134129
World Knee Tibial Monotrial - UC 122-18-0590SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215081218
World Knee System121-20-8510SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037635
World Knee System121-20-8200SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037550
World Knee System121-20-6530SIGNATURE ORTHOPAEDICS PTY LTDJWH09348215037338
All Poly Monotrial UC122-18-0472SIGNATURE ORTHOPAEDICS PTY LTDHWT09348215081294
World Knee CR All Poly Tibia121-20-6918SIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215116064
World Knee Spherical Patella – Finned Peg Vit-E 121-20-8922ESIGNATURE ORTHOPAEDICS PTY LTDJWH MBH09348215134266