Skip to content
Scan

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

Clearance record K200431

3D GraftRasp System · Surgentec · decided 2020-05-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
20mm DilatorSR10-6019Surgentec, LLCFMF HTR00858406007280
3/4 inch CobbSR10-5010Surgentec, LLCFMF HTR00858406007716
17mm DilatorSR10-6018Surgentec, LLCFMF HTR00858406007273
6mm DilatorSR10-6015Surgentec, LLCFMF HTR00858406007259
GraftRasp Sterilization TraySR10-7020Surgentec, LLCFMF HTR00858406007631
13mm DilatorSR10-6017Surgentec, LLCFMF HTR00858406007532