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

Clearance record K203595

DynaFuse Fixation System · MedShape, Inc. · decided 2022-01-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
DynaNail Helix, Headed, 60mm3200-00-7060Medshape, Inc.HWCM97032000070600
DynaNail Helix, Headed, 95mm3200-00-7095Medshape, Inc.HWCM97032000070950
Parallel Pin Guide, DynaFuse3100-07-0001Medshape, Inc.HTYM97031000700010
DynaNail Helix, Headed, 75mm3200-00-7075Medshape, Inc.HWCM97032000070750
DynaNail Helix, Headless, 110mm3200-01-7110Medshape, Inc.HWCM97032000171100
DynaNail Helix, Headed, 105mm3200-00-7105Medshape, Inc.HWCM97032000071050
DynaNail Helix, Headless, 70mm3200-01-7070Medshape, Inc.HWCM97032000170700
DynaNail Helix, Headless, 65mm3200-01-7065Medshape, Inc.HWCM97032000170650
Trajectory Wire, DynaFuse3100-04-0001Medshape, Inc.LXHM97031000400010
DynaNail Helix, Headed, 50mm3200-00-7050Medshape, Inc.HWCM97032000070500
DynaNail Helix, Headless, 95mm3200-01-7095Medshape, Inc.HWCM97032000170950
Tube Caddy, DynaFuse3100-12-0001Medshape, Inc.JECM97031001200010
DynaNail Helix, Headed, 55mm3200-00-7055Medshape, Inc.HWCM97032000070550
Depth Gauge, 150mm DynaFuse3100-05-0150Medshape, Inc.LXHM973031000501500
DynaNail Helix, Headless, 60mm3200-01-7060Medshape, Inc.HWCM97032000170600
DynaNail Helix, Headed, 80mm3200-00-7080Medshape, Inc.HWCM97032000070800
DynaNail Helix, Headless, 85mm3200-01-7085Medshape, Inc.HWCM97032000170850
DynaNail Helix, Washer, 15 mm3300-00-1515Medshape, Inc.HTNM97033000015150
DynaNail Helix, Headed, 65mm3200-00-7065Medshape, Inc.HWCM97032000070650
DynaNail Helix, Headed, 90mm3200-00-7090Medshape, Inc.HWCM97032000070900
DynaNail Helix, Headless, 75mm3200-01-7075Medshape, Inc.HWCM97032000170750
DynaNail Helix, Headless, 90mm3200-01-7090Medshape, Inc.HWCM97032000170900
DynaNail Helix, Headed, 100mm3200-00-7100Medshape, Inc.HWCM97032000071000
Tissue Protector, DynaFuse3100-09-0001Medshape, Inc.JECM97031000900010
DynaFuse 5mm Drill3100-01-0005Medshape, Inc.LXHM97031000100050