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

Clearance record K201900

3D GraftRasp System · Surgentec · decided 2020-09-03 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
GraftRasp Teeth and Set Screw - Bladed3D-D05-07Surgentec, LLCHTR00858406007709
Decortication Rasp - Curved3D-D05-05Surgentec, LLCHTR00858406007464
Decortication Rasp - Straight3D-D05-04 Surgentec, LLCHTR00858406007402
Flexible Pusher Tip and Set Screw3D-T01-07Surgentec, LLCHTR00858406007600
Decortication Rasp- Straight 3D-D05-04Surgentec, LLCHTR00858406007174
GraftRasp Teeth and Set Screw - Curved3D-D05-01Surgentec, LLCHTR00858406007075
GraftRasp Teeth and Set Screw- Straight3D-D05-06Surgentec, LLCHTR00858406007563
Bone Graft Funnel 3D-F05-01Surgentec, LLCHTR00858406007457
Decortication Rasp - Fixed Curved 3D-D05-03Surgentec, LLCHTR00858406007358