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

Clearance record K203002

SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System · Bonebridge AG · decided 2021-10-05 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Cortical Screw ø3.5mm L42mmB-324042Bonebridge AGHRS07640187461121
TRIFT 3.5mm 1/3 Tubular Plate, 13 HoleB-210013Bonebridge AGHRS07640187461442
Cortical Screw ø3.5mm L10mmB-324010Bonebridge AGHRS07640187460964
Cortical Screw ø3.5mm L22mmB-324022Bonebridge AGHRS07640187461022
Cortical Screw ø3.5mm L60mmB-324060Bonebridge AGHRS07640187461183
TRIFT 3.5mm 1/3 Tubular Plate, 5 HoleB-210005Bonebridge AGHRS07640187461404
Cortical Screw ø3.5mm L38mmB-324038Bonebridge AGHRS07640187461107
Cortical Screw ø3.5mm L36mmB-324036Bonebridge AGHRS07640187461091
Cortical Screw ø3.5mm L24mmB-324024Bonebridge AGHRS07640187461039
TRIFT 3.5mm 1/3 Tubular Plate, 11 HoleB-210011Bonebridge AGHRS07640187461435
TRIFT 3.5mm 1/3 Tubular Plate, 9 HoleB-210009Bonebridge AGHRS07640187461428
Cortical Screw ø3.5mm L46mmB-324046Bonebridge AGHRS07640187461145
Cortical Screw ø3.5mm L50mmB-324050Bonebridge AGHRS07640187461169
TRIFT 3.5mm 1/3 Tubular Plate, 3 HoleB-210003Bonebridge AGHRS07640187461398
Cortical Screw ø3.5mm L48mmB-324048Bonebridge AGHRS07640187461152
Cortical Screw ø3.5mm L26mmB-324026Bonebridge AGHRS07640187461046
TRIFT 3.5mm 1/3 Tubular Plate, 7 HoleB-210007Bonebridge AGHRS07640187461411
Cortical Screw ø3.5mm L12mmB-324012Bonebridge AGHRS07640187460971
Cortical Screw ø3.5mm L20mmB-324020Bonebridge AGHRS07640187461015
Cortical Screw ø3.5mm L55mmB-324055Bonebridge AGHRS07640187461176
Cortical Screw ø3.5mm L34mmB-324034Bonebridge AGHRS07640187461084
Cortical Screw ø3.5mm L16mmB-324016Bonebridge AGHRS07640187460995
Cortical Screw ø3.5mm L28mmB-324028Bonebridge AGHRS07640187461053
Cortical Screw ø3.5mm L44mmB-324044Bonebridge AGHRS07640187461138
Cortical Screw ø3.5mm L18mmB-324018Bonebridge AGHRS07640187461008