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

Clearance record K093772

SYNTHES STERNAL FIXATION SYSTEM · Synthes · decided 2010-03-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)413.578Synthes GmbHHRS HWC JDQ20887587048809
(unnamed)04.501.116SSynthes GmbHHRS HWC10887587017440
(unnamed)497.691Synthes GmbHHRS HWC JDQ JEY MQN20887587056583
(unnamed)460.037Synthes GmbHHRS HWC JDQ10887587055152
(unnamed)497.698Synthes GmbHHRS HWC JDQ JEY MQN20887587056729
(unnamed)460.037SSynthes GmbHHRS HWC JDQ10887587055169
(unnamed)460.022.05SSynthes GmbHHRS HWC JDQ20887587054954
(unnamed)04.501.118SSynthes GmbHHRS HWC10887587017471
(unnamed)04.501.120.05Synthes GmbHHRS HWC20887587017492
(unnamed)460.045Synthes GmbHHRS HWC JDQ10887587055237
(unnamed)460.038SSynthes GmbHHRS HWC JDQ10887587055183
(unnamed)04.501.120SSynthes GmbHHRS HWC10887587017501
(unnamed)460.027Synthes GmbHHRS HWC JDQ10887587055015
(unnamed)460.022Synthes GmbHHRS HWC JDQ10887587054940
(unnamed)04.501.116.05Synthes GmbHHRS HWC20887587017430
(unnamed)497.695Synthes GmbHHRS HWC JDQ JEY MQN20887587056668
(unnamed)460.028SSynthes GmbHHRS HWC JDQ10887587055060
(unnamed)460.038Synthes GmbHHRS HWC JDQ10887587055176
(unnamed)413.584Synthes GmbHHRS HWC JDQ20887587048861
(unnamed)460.035SSynthes GmbHHRS HWC JDQ10887587055114
(unnamed)460.024SSynthes GmbHHRS HWC JDQ10887587055008
(unnamed)497.690Synthes GmbHHRS HWC JDQ JEY MQN20887587056569
(unnamed)497.693Synthes GmbHHRS HWC JDQ JEY MQN20887587056620
(unnamed)413.588Synthes GmbHHRS HWC JDQ20887587048908
(unnamed)04.501.118.05Synthes GmbHHRS HWC20887587017461